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        <generator>Centers for Medicare and Medicaid Services</generator><item><title>G240271-NCT06133387</title><pubDate>Tue, 25 Feb 2025 15:08:10 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240271-nct06133387</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240271-nct06133387</guid><description><![CDATA[<p>approval_date: Fri, 14 Feb 2025 05:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06133387?term=NCT06133387&rank=1title:</p><p>ide_number: G240271</p><p>nct_number: NCT06133387</p><p>sponsor_name: EndoQuest Robotics, Inc.</p><p>study_title: PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System</p>]]></description></item><item><title>G240068-NCT06556693</title><pubDate>Tue, 25 Feb 2025 15:06:32 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240068-nct06556693</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240068-nct06556693</guid><description><![CDATA[<p>approval_date: Tue, 28 Jan 2025 05:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06556693title:</p><p>ide_number: G240068</p><p>nct_number: NCT06556693</p><p>sponsor_name: Zoll Medical Corporation</p><p>study_title: Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy</p>]]></description></item><item><title>G210078-NCT06693011</title><pubDate>Tue, 25 Feb 2025 15:04:00 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210078-nct06693011</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210078-nct06693011</guid><description><![CDATA[<p>approval_date: Tue, 28 Jan 2025 05:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06693011?term=NCT06693011&rank=1title:</p><p>ide_number: G210078</p><p>nct_number: NCT06693011</p><p>sponsor_name: Cerus Endovascular, Inc.</p><p>study_title: Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial</p>]]></description></item><item><title>G230327-NCT06735833</title><pubDate>Tue, 25 Feb 2025 15:02:29 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-0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230142-nct06052072</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230142-nct06052072</guid><description><![CDATA[<p>approval_date: Wed, 22 Jan 2025 05:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06052072?tab=tabletitle:</p><p>ide_number: G230142</p><p>nct_number: NCT06052072</p><p>sponsor_name: Gradient Denervation Technologies</p><p>study_title: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients with Pulmonary Hypertension Group 2 (PreVail-PH2 Study)</p>]]></description></item><item><title>G160216-NCT06676163</title><pubDate>Tue, 21 Jan 2025 07:33:09 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g160216-nct06676163</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g160216-nct06676163</guid><description><![CDATA[<p>approval_date: Fri, 17 Jan 2025 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06676163?term=NCT06676163&rank=1title:</p><p>ide_number: G160216</p><p>nct_number: NCT06676163</p><p>sponsor_name: Gold T-Tech </p><p>study_title: Morphology Recurrence Plot Mapping</p>]]></description></item><item><title>G230033-NCT05882344</title><pubDate>Tue, 21 Jan 2025 07:32:05 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230033-nct05882344</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230033-nct05882344</guid><description><![CDATA[<p>approval_date: Fri, 17 Jan 2025 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05882344?term=NCT05882344&rank=1title:</p><p>ide_number: G230033</p><p>nct_number: NCT05882344</p><p>sponsor_name: Vanderbilt University Medical Center</p><p>study_title: Cholinergic Deep Brain Stimulation for Alzheimer’s Disease</p>]]></description></item><item><title>G240185-NCT06608823</title><pubDate>Tue, 21 Jan 2025 07:30:59 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240185-nct06608823</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240185-nct06608823</guid><description><![CDATA[<p>approval_date: Wed, 08 Jan 2025 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06608823?term=NCT06608823&rank=1title:</p><p>ide_number: G240185</p><p>nct_number: NCT06608823</p><p>sponsor_name: JenaValve Technology, Inc.</p><p>study_title: A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation</p>]]></description></item><item><title>G240273-NCT06712251</title><pubDate>Tue, 21 Jan 2025 07:29:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240273-nct06712251</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240273-nct06712251</guid><description><![CDATA[<p>approval_date: Wed, 08 Jan 2025 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06712251?term=NCT06712251&rank=1title:</p><p>ide_number: G240273</p><p>nct_number: NCT06712251</p><p>sponsor_name: Venova Medical</p><p>study_title: Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System</p>]]></description></item><item><title>G240157-NCT06451614</title><pubDate>Tue, 21 Jan 2025 07:28:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240157-nct06451614</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240157-nct06451614</guid><description><![CDATA[<p>approval_date: Tue, 07 Jan 2025 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06451614?term=NCT06451614&rank=1title:</p><p>ide_number: G240157</p><p>nct_number: NCT06451614</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)</p>]]></description></item><item><title>G240265-NCT06676072</title><pubDate>Tue, 21 Jan 2025 07:27:28 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240265-nct06676072</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240265-nct06676072</guid><description><![CDATA[<p>approval_date: Tue, 07 Jan 2025 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06676072?term=NCT06676072&rank=1title:</p><p>ide_number: G240265</p><p>nct_number: NCT06676072</p><p>sponsor_name: Abbott Medical Devices</p><p>study_title: Safety and Effectiveness of the TactiFlex SE Catheter and Volt Pulsed Field Ablation (PFA) Generator in Subjects with Paroxysmal Atrial Fibrillation</p>]]></description></item><item><title>G240222-NCT06662500</title><pubDate>Tue, 21 Jan 2025 07:24:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240222-nct06662500</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240222-nct06662500</guid><description><![CDATA[<p>approval_date: Tue, 07 Jan 2025 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06662500?term=NCT06662500&rank=1title:</p><p>ide_number: G240222</p><p>nct_number: NCT06662500</p><p>sponsor_name: Shockwave Medical, Inc.</p><p>study_title: Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)</p>]]></description></item><item><title>G240216-NCT06615154</title><pubDate>Mon, 06 Jan 2025 10:25:49 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240216-nct06615154</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240216-nct06615154</guid><description><![CDATA[<p>approval_date: Fri, 20 Dec 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06615154?term=NCT06615154&rank=1title:</p><p>ide_number: G240216</p><p>nct_number: NCT06615154</p><p>sponsor_name: Haemonetics Corporation</p><p>study_title: AMBULATE EXPAND Trial TP-CLN-1006607 A Multi-Center, Prospective, Single Arm, Pivotal Trial to Evaluate the Safety and Efficacy of the VASCADE MVP® XL Venous Vascular Closure System (VVCS) for the Management of the Femoral Venotomy After Catheter-Based Interventions Performed Utilizing 16-17F Outer Diameter (OD) Sheaths</p>]]></description></item><item><title>G230296-1-NCT06183684</title><pubDate>Mon, 06 Jan 2025 10:24:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230296-1-nct06183684</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230296-1-nct06183684</guid><description><![CDATA[<p>approval_date: Fri, 20 Dec 2024 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06183684?term=NCT06183684&rank=1title:</p><p>ide_number: G230296</p><p>nct_number: NCT06183684</p><p>sponsor_name: Laplace Interventional, Inc</p><p>study_title: Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System</p>]]></description></item><item><title>G240206-NCT06613568</title><pubDate>Mon, 06 Jan 2025 10:23:59 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240206-nct06613568</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240206-nct06613568</guid><description><![CDATA[<p>approval_date: Thu, 19 Dec 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06613568title:</p><p>ide_number: G240206</p><p>nct_number: NCT06613568</p><p>sponsor_name: Diality Inc.</p><p>study_title: Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Subjects With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens</p>]]></description></item><item><title>G230145-NCT06556654</title><pubDate>Mon, 06 Jan 2025 10:22:59 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230145-nct06556654-1</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230145-nct06556654-1</guid><description><![CDATA[<p>approval_date: Thu, 19 Dec 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06556654title:</p><p>ide_number: G230145</p><p>nct_number: NCT06556654</p><p>sponsor_name: W.L.Gore &#x26; Associates</p><p>study_title: Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction</p>]]></description></item><item><title>G230145-NCT06556654</title><pubDate>Mon, 06 Jan 2025 07:58:07 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230145-nct06556654-0</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230145-nct06556654-0</guid><description><![CDATA[<p>approval_date: Thu, 19 Dec 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06556654title:</p><p>ide_number: G230145</p><p>nct_number: NCT06556654</p><p>sponsor_name: W.L.Gore &#x26; Associates</p><p>study_title: Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction</p>]]></description></item><item><title>G230145-NCT06556654</title><pubDate>Mon, 23 Dec 2024 06:20:49 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230145-nct06556654</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230145-nct06556654</guid><description><![CDATA[<p>approval_date: Thu, 19 Dec 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06556654title:</p><p>ide_number: G230145</p><p>nct_number: NCT06556654</p><p>sponsor_name: W.L.Gore &#x26; Associates</p><p>study_title: Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction</p>]]></description></item><item><title>G220002-NCT06498960</title><pubDate>Mon, 16 Dec 2024 06:30:09 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220002-nct06498960</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220002-nct06498960</guid><description><![CDATA[<p>approval_date: Wed, 11 Dec 2024 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06498960?term=NCT06498960&rank=1title:</p><p>ide_number: G220002</p><p>nct_number: NCT06498960</p><p>sponsor_name: CereVasc Inc</p><p>study_title: Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® EShunt® System in the Treatment of Normal Pressure Hydrocephalus</p>]]></description></item><item><title>G230220-NCT06134167</title><pubDate>Mon, 16 Dec 2024 06:28:52 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230220-nct06134167</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230220-nct06134167</guid><description><![CDATA[<p>approval_date: Wed, 11 Dec 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06134167title:</p><p>ide_number: G230220</p><p>nct_number: NCT06134167</p><p>sponsor_name: Balmoral Medical company</p><p>study_title: A Prospective, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants with Transfemoral Amputations</p>]]></description></item><item><title>G210105-NCT06605638</title><pubDate>Mon, 16 Dec 2024 06:27:30 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210105-nct06605638</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210105-nct06605638</guid><description><![CDATA[<p>approval_date: Wed, 11 Dec 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06605638?term=NCT06605638&rank=1title:</p><p>ide_number: G210105</p><p>nct_number: NCT06605638</p><p>sponsor_name: Rayner Surgical, Inc. </p><p>study_title: Rayner Intraocular Lenses Limited</p>]]></description></item><item><title>G240190-NCT06651632</title><pubDate>Mon, 16 Dec 2024 06:26:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240190-nct06651632</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240190-nct06651632</guid><description><![CDATA[<p>approval_date: Fri, 06 Dec 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06651632?term=NCT06651632&rank=1title:</p><p>ide_number: G240190</p><p>nct_number: NCT06651632</p><p>sponsor_name: PROCEPT BioRobotics</p><p>study_title: WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer</p>]]></description></item><item><title>G240044-NCT06492733</title><pubDate>Tue, 10 Dec 2024 06:28:40 -0500</pubDate><link>https://www.cms.gov//cms-guide-medical-technology-companies-and-other-interested-parties/coverage/g240044-nct06492733</link><guid>https://www.cms.gov//cms-guide-medical-technology-companies-and-other-interested-parties/coverage/g240044-nct06492733</guid><description><![CDATA[<p>approval_date: Thu, 21 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06492733?term=NCT06492733&rank=1title:</p><p>ide_number: G240044</p><p>nct_number: NCT06492733</p><p>sponsor_name: Versono Medical Ltd</p><p>study_title: A Pivotal, Single-arm, Multi-centre, Prospective Clinical Investigation to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW)</p>]]></description></item><item><title>G220310-1-NCT06095531 </title><pubDate>Mon, 25 Nov 2024 06:27:58 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220310-1-nct06095531</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220310-1-nct06095531</guid><description><![CDATA[<p>approval_date: Thu, 21 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06095531?term=Bioresorbable%20cranial%20flap&rank=1title:</p><p>ide_number: G220310-1</p><p>nct_number: NCT06095531</p><p>sponsor_name: RevBio</p><p>study_title: A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive Based on Imaging and Patient Reported Outcomes</p>]]></description></item><item><title>G240166-NCT06653387</title><pubDate>Tue, 19 Nov 2024 06:39:31 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240166-nct06653387</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240166-nct06653387</guid><description><![CDATA[<p>approval_date: Wed, 13 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06653387?term=NCT06653387&rank=1title:</p><p>ide_number: G240166</p><p>nct_number: NCT06653387</p><p>sponsor_name: InspireMD</p><p>study_title: A Multicenter, Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System (80cm) When Used in Conjunction With the FDA-cleared ENROUTE Transcarotid Neuroprotection System (NPS) in Patients at High Risk for Adverse Events From Carotid Endarterectomy Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach.</p>]]></description></item><item><title>G210349-NCT06540079</title><pubDate>Tue, 19 Nov 2024 06:38:24 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210349-nct06540079</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210349-nct06540079</guid><description><![CDATA[<p>approval_date: Wed, 13 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06540079?term=NCT06540079&rank=1title:</p><p>ide_number: G210349</p><p>nct_number: NCT06540079</p><p>sponsor_name: Biotronik, Inc.</p><p>study_title: BIOTRONIK Conduction System Pacing with the Solia Lead</p>]]></description></item><item><title>G230339-NCT06071429</title><pubDate>Tue, 19 Nov 2024 06:36:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230339-nct06071429</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230339-nct06071429</guid><description><![CDATA[<p>approval_date: Wed, 13 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06071429?term=NCT06071429&rank=1title:</p><p>ide_number: G230339</p><p>nct_number: NCT06071429</p><p>sponsor_name: R3 Vascular Inc.</p><p>study_title: Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease</p>]]></description></item><item><title>G230087-NCT06271590</title><pubDate>Tue, 19 Nov 2024 06:35:25 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230087-nct06271590</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230087-nct06271590</guid><description><![CDATA[<p>approval_date: Tue, 12 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06271590?term=NCT06271590&rank=1title:</p><p>ide_number: G230087</p><p>nct_number: NCT06271590</p><p>sponsor_name: Concept Medical Inc.</p><p>study_title: The MAGICAL SV Trial - a Prospective, Multicenter, Randomized, Two-Arm, Single-blind Non Inferiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Small Vessels in Patients with Coronary Artery Disease</p>]]></description></item><item><title>G240089-NCT06576427</title><pubDate>Tue, 19 Nov 2024 06:34:09 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240089-nct06576427</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240089-nct06576427</guid><description><![CDATA[<p>approval_date: Tue, 12 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06576427?term=NCT06576427&rank=1title:</p><p>ide_number: G240089</p><p>nct_number: NCT06576427</p><p>sponsor_name: Neptune Medical</p><p>study_title: Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II</p>]]></description></item><item><title>G200273-NCT06289985</title><pubDate>Tue, 19 Nov 2024 06:32:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200273-nct06289985</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200273-nct06289985</guid><description><![CDATA[<p>approval_date: Tue, 12 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06289985?term=NCT06289985&rank=1title:</p><p>ide_number: G200273</p><p>nct_number: NCT06289985</p><p>sponsor_name: Medical University of South Carolina</p><p>study_title: STEP: StrokeNet Thrombectomy Endovascular Platform</p>]]></description></item><item><title>G240142-NCT06529835</title><pubDate>Tue, 12 Nov 2024 10:53:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240142-nct06529835</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240142-nct06529835</guid><description><![CDATA[<p>approval_date: Tue, 05 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06529835?term=NCT06529835&rank=1title:</p><p>ide_number: G240142</p><p>nct_number: NCT06529835</p><p>sponsor_name: Auxilium Biotechnologies</p><p>study_title: A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)</p>]]></description></item><item><title>G240096-NCT06611748</title><pubDate>Tue, 12 Nov 2024 10:52:34 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240096-nct06611748</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240096-nct06611748</guid><description><![CDATA[<p>approval_date: Mon, 04 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06611748?term=NCT06611748&rank=1title:</p><p>ide_number: G240096</p><p>nct_number: NCT06611748</p><p>sponsor_name: MetroHealth Medical Center</p><p>study_title: Evaluation of a Simple Neuroprosthesis for Restoration of Hand Function in Cervical Spinal Cord Injury</p>]]></description></item><item><title>G240122-NCT06501872</title><pubDate>Tue, 12 Nov 2024 10:51:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240122-nct06501872</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240122-nct06501872</guid><description><![CDATA[<p>approval_date: Mon, 04 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06501872?term=NCT06501872&rank=1title:</p><p>ide_number: G240122</p><p>nct_number: NCT06501872</p><p>sponsor_name: Bjoern D. Suckow</p><p>study_title: Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms</p>]]></description></item><item><title>G210031-NCT06347796</title><pubDate>Tue, 12 Nov 2024 10:49:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210031-nct06347796</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210031-nct06347796</guid><description><![CDATA[<p>approval_date: Thu, 24 Oct 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06347796?term=NCT06347796&rank=1title:</p><p>ide_number: G210031</p><p>nct_number: NCT06347796</p><p>sponsor_name: The University of Texas Medical Branch, Galveston</p><p>study_title: Chronic Subdural Hematoma Treatment with Embolization Versus Surgery Study (CHESS)</p>]]></description></item><item><title>G230317-NCT06087575</title><pubDate>Tue, 12 Nov 2024 10:48:39 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230317-nct06087575</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230317-nct06087575</guid><description><![CDATA[<p>approval_date: Mon, 04 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06087575title:</p><p>ide_number: G230317</p><p>nct_number: NCT06087575</p><p>sponsor_name: Supira Medical</p><p>study_title: Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial</p>]]></description></item><item><title>G230217-NCT06485206</title><pubDate>Tue, 12 Nov 2024 10:47:36 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230217-nct06485206</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230217-nct06485206</guid><description><![CDATA[<p>approval_date: Mon, 04 Nov 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06485206?term=NCT06485206&rank=1title:</p><p>ide_number: G230217</p><p>nct_number: NCT06485206</p><p>sponsor_name: ZimVie</p><p>study_title: A Clinical Investigation Evaluating Safety and Effectiveness of Primary Hybrid Construct of Mobi-C and ACDF in the Treatment of Two-level Symptomatic Degenerative Disc Disease in the Cervical Spine.</p>]]></description></item><item><title>G240117-NCT06611579</title><pubDate>Fri, 18 Oct 2024 10:29:15 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240117-nct06611579</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240117-nct06611579</guid><description><![CDATA[<p>approval_date: Tue, 15 Oct 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06611579title:</p><p>ide_number: G240117</p><p>nct_number: NCT06611579</p><p>sponsor_name: inQB8 Medical Technologies, LLC</p><p>study_title: A Clinical Study of the InQB8 Transcatheter Tricuspid Valve Replacement System</p>]]></description></item><item><title>G230350-NCT06154005</title><pubDate>Fri, 18 Oct 2024 10:25:51 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230350-nct06154005</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230350-nct06154005</guid><description><![CDATA[<p>approval_date: Fri, 11 Oct 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06154005title:</p><p>ide_number: G230350</p><p>nct_number: NCT06154005</p><p>sponsor_name: Theradaptive, Inc.</p><p>study_title: OsteoAdapt SP Advanced Bone Graft</p>]]></description></item><item><title>G230284-NCT06445608</title><pubDate>Fri, 18 Oct 2024 10:22:49 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230284-nct06445608</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230284-nct06445608</guid><description><![CDATA[<p>approval_date: Fri, 11 Oct 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06445608title:</p><p>ide_number: G230284</p><p>nct_number: NCT06445608</p><p>sponsor_name: Kardion Inc</p><p>study_title: PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm</p>]]></description></item><item><title>G210046-NCT04820764</title><pubDate>Fri, 18 Oct 2024 10:18:45 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210046-nct04820764</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210046-nct04820764</guid><description><![CDATA[<p>approval_date: Fri, 11 Oct 2024 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT04820764title:</p><p>ide_number: G210046</p><p>nct_number: NCT04820764</p><p>sponsor_name: CardioMech AS</p><p>study_title: Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)</p>]]></description></item><item><title>G240058-NCT06568003</title><pubDate>Tue, 15 Oct 2024 06:08:27 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240058-nct06568003</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240058-nct06568003</guid><description><![CDATA[<p>approval_date: Wed, 09 Oct 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06568003title:</p><p>ide_number: G240058</p><p>nct_number: NCT06568003</p><p>sponsor_name: Jenscare Innovation Inc.</p><p>study_title: TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - SafetY and Clinical Performance</p>]]></description></item><item><title>G240119-NCT06526195</title><pubDate>Tue, 15 Oct 2024 06:07:09 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240119-nct06526195</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240119-nct06526195</guid><description><![CDATA[<p>approval_date: Tue, 08 Oct 2024 04:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06526195title:</p><p>ide_number: G240119</p><p>nct_number: NCT06526195</p><p>sponsor_name: Abbott Medical Devices</p><p>study_title: Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure</p>]]></description></item><item><title>G200100-NCT06492174</title><pubDate>Tue, 01 Oct 2024 06:23:34 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200100-nct06492174</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200100-nct06492174</guid><description><![CDATA[<p>approval_date: Thu, 26 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06492174?term=NCT06492174&rank=1title:</p><p>ide_number: G200100</p><p>nct_number: NCT06492174</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)</p>]]></description></item><item><title>G230321-NCT06035120</title><pubDate>Tue, 01 Oct 2024 06:22:23 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230321-nct06035120</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230321-nct06035120</guid><description><![CDATA[<p>approval_date: Wed, 25 Sep 2024 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06035120?term=NCT06035120&rank=1title:</p><p>ide_number: G230321</p><p>nct_number: NCT06035120</p><p>sponsor_name: Pulmonx Corporation</p><p>study_title: An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema: The CONVERT II Trial</p>]]></description></item><item><title>G240108-NCT06457685</title><pubDate>Tue, 01 Oct 2024 06:21:10 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240108-nct06457685</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240108-nct06457685</guid><description><![CDATA[<p>approval_date: Mon, 23 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06457685?term=NCT06457685&rank=1title:</p><p>ide_number: G240108</p><p>nct_number: NCT06457685</p><p>sponsor_name: Amplitude Vascular Systems, Inc.</p><p>study_title: Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels with Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease</p>]]></description></item><item><title>G230342-NCT06370182</title><pubDate>Tue, 01 Oct 2024 06:19:52 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230342-nct06370182</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230342-nct06370182</guid><description><![CDATA[<p>approval_date: Tue, 24 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06370182?term=NCT06370182&rank=1title:</p><p>ide_number: G230342</p><p>nct_number: NCT06370182</p><p>sponsor_name: Anaconda Biomed S.L.</p><p>study_title: A Prospective, Randomized, Dual-arm Multi-center Study to Assess the Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device in Combination With a Stent Retriever</p>]]></description></item><item><title>G220315-NCT06552637</title><pubDate>Tue, 01 Oct 2024 06:18:43 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220315-nct06552637</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220315-nct06552637</guid><description><![CDATA[<p>approval_date: Mon, 23 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06552637?term=NCT06552637&rank=1title:</p><p>ide_number: G220315</p><p>nct_number: NCT06552637</p><p>sponsor_name: VisCardia Inc.</p><p>study_title: RECOVER-HF - RandomizEd, Multi-Center, Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation (SDS) for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure</p>]]></description></item><item><title>G230315-NCT06455098</title><pubDate>Tue, 01 Oct 2024 06:17:28 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230315-nct06455098</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230315-nct06455098</guid><description><![CDATA[<p>approval_date: Mon, 23 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06455098?term=NCT06455098&rank=1title:</p><p>ide_number: G230315</p><p>nct_number: NCT06455098</p><p>sponsor_name: Biosense Webster, Inc.</p><p>study_title: Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter</p>]]></description></item><item><title>G190128-NCT06465745</title><pubDate>Tue, 24 Sep 2024 06:10:03 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g190128-nct06465745</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g190128-nct06465745</guid><description><![CDATA[<p>approval_date: Thu, 12 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06465745title:</p><p>ide_number: G190128</p><p>nct_number: NCT06465745</p><p>sponsor_name: 4C Medical Technologies, Inc.</p><p>study_title: AltaValve Pivotal Trial</p>]]></description></item><item><title>G220025-NCT06330493</title><pubDate>Tue, 24 Sep 2024 06:08:47 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220025-nct06330493</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220025-nct06330493</guid><description><![CDATA[<p>approval_date: Mon, 16 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06330493?term=NCT06330493&rank=1title:</p><p>ide_number: G220025</p><p>nct_number: NCT06330493</p><p>sponsor_name: Acotec Scientific Co., Ltd</p><p>study_title: Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapopliteal Obstructions in Patients With Chronic Limb-Threatening Ischemia</p>]]></description></item><item><title>G230344-NCT06447116</title><pubDate>Tue, 24 Sep 2024 06:07:33 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230344-nct06447116</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230344-nct06447116</guid><description><![CDATA[<p>approval_date: Mon, 16 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06447116?term=NCT06447116&rank=1title:</p><p>ide_number: G230344</p><p>nct_number: NCT06447116</p><p>sponsor_name: Jacobs institute</p><p>study_title: An EFS to Evaluate the Safety and Preliminary Effectiveness of the CGuard Prime™ Carotid Stent Placement in the Procedure Setting of Acute Ischemic Stroke</p>]]></description></item><item><title>G240116-NCT06364215</title><pubDate>Tue, 17 Sep 2024 06:09:18 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240116-nct06364215</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240116-nct06364215</guid><description><![CDATA[<p>approval_date: Tue, 10 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06364215title:</p><p>ide_number: G240116</p><p>nct_number: NCT06364215</p><p>sponsor_name: Brigham and Women's Hospital</p><p>study_title: Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation</p>]]></description></item><item><title>G240071-NCT06410313</title><pubDate>Tue, 17 Sep 2024 06:07:50 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240071-nct06410313</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240071-nct06410313</guid><description><![CDATA[<p>approval_date: Tue, 10 Sep 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06410313title:</p><p>ide_number: G240071</p><p>nct_number: NCT06410313</p><p>sponsor_name: Medinol Ltd.</p><p>study_title: First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease</p>]]></description></item><item><title>G220336-NCT05741463</title><pubDate>Tue, 03 Sep 2024 06:27:51 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220336-nct05741463</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220336-nct05741463</guid><description><![CDATA[<p>approval_date: Tue, 27 Aug 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05741463?term=NCT05741463&rank=1title:</p><p>ide_number: G220336</p><p>nct_number: NCT05741463</p><p>sponsor_name: Becton, Dickinson and Company</p><p>study_title: A Prospective, Multi-Center, Single-Blind, Randomized, Active-Controlled- Study of BD ORC Original Absorbable Hemostat Compared with Surgicel® Original Absorbable Hemostat</p>]]></description></item><item><title>G220218-NCT06056817 </title><pubDate>Tue, 27 Aug 2024 06:03:09 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220218-nct06056817</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220218-nct06056817</guid><description><![CDATA[<p>approval_date: Wed, 21 Aug 2024 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06056817?term=%E2%80%A2%09Chronic%20Evaluation%20of%20Novel%20Pacemaker%20System&rank=1title:</p><p>ide_number: G220218</p><p>nct_number: NCT06056817</p><p>sponsor_name: Calyan Technologies</p><p>study_title: Chronic Evaluation of Novel Pacemaker System</p>]]></description></item><item><title>G240017-NCT06418880</title><pubDate>Tue, 27 Aug 2024 06:01:54 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240017-nct06418880</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240017-nct06418880</guid><description><![CDATA[<p>approval_date: Wed, 21 Aug 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06418880title:</p><p>ide_number: G240017</p><p>nct_number: NCT06418880</p><p>sponsor_name: Emory University</p><p>study_title: Automated Insulin Delivery for Inpatients With Dysglycemia (AIDING) Randomized Controlled Trial</p>]]></description></item><item><title>G230265-NCT06506942</title><pubDate>Tue, 20 Aug 2024 06:20:38 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230265-nct06506942</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230265-nct06506942</guid><description><![CDATA[<p>approval_date: Wed, 07 Aug 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06506942?term=NCT06506942&rank=1title:</p><p>ide_number: G230265</p><p>nct_number: NCT06506942</p><p>sponsor_name: TRiCares</p><p>study_title: The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study</p>]]></description></item><item><title>G230341-NCT06488820</title><pubDate>Tue, 20 Aug 2024 06:19:23 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230341-nct06488820</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230341-nct06488820</guid><description><![CDATA[<p>approval_date: Wed, 07 Aug 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06488820?term=NCT06488820&rank=1title:</p><p>ide_number: G230341</p><p>nct_number: NCT06488820</p><p>sponsor_name: Texas Cardiac Arrhythmia Research Foundation</p><p>study_title: Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers</p>]]></description></item><item><title>G240099-NCT06464926</title><pubDate>Tue, 20 Aug 2024 06:18:12 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240099-nct06464926</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240099-nct06464926</guid><description><![CDATA[<p>approval_date: Wed, 07 Aug 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06464926title:</p><p>ide_number: G240099</p><p>nct_number: NCT06464926</p><p>sponsor_name: Enterra Medical, Inc.</p><p>study_title: A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System</p>]]></description></item><item><title>G240026-NCT06333015</title><pubDate>Tue, 20 Aug 2024 06:16:52 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240026-nct06333015</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240026-nct06333015</guid><description><![CDATA[<p>approval_date: Fri, 02 Aug 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06333015title:</p><p>ide_number: G240026</p><p>nct_number: NCT06333015</p><p>sponsor_name: Bausch &#x26; Lomb Incorporated</p><p>study_title: A Prospective, Multicenter, Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction</p>]]></description></item><item><title>G230106-NCT06027996</title><pubDate>Tue, 20 Aug 2024 06:15:44 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230106-nct06027996</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230106-nct06027996</guid><description><![CDATA[<p>approval_date: Fri, 16 Aug 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06027996?term=Melodi%20Absorbable%20Antibacterial%20Matrix&rank=1title:</p><p>ide_number: G230106</p><p>nct_number: NCT06027996</p><p>sponsor_name: Melodi Health, Inc.</p><p>study_title: Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)</p>]]></description></item><item><title>G210332-NCT06463080</title><pubDate>Tue, 20 Aug 2024 06:14:35 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210332-nct06463080</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210332-nct06463080</guid><description><![CDATA[<p>approval_date: Fri, 02 Aug 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06463080title:</p><p>ide_number: G210332</p><p>nct_number: NCT06463080</p><p>sponsor_name: BVI</p><p>study_title: A randomized, assessor-masked, controlled, multi-center, non-inferiority comparison study to evaluate safety and effectiveness of the NuVisc PRO versus Amvisc® Plus in patients undergoing cataract surgery via the anterior chamber</p>]]></description></item><item><title>G230153-NCT06216301</title><pubDate>Fri, 16 Aug 2024 08:24:29 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230153-nct06216301</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230153-nct06216301</guid><description><![CDATA[<p>approval_date: Tue, 23 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06216301title:</p><p>ide_number: G230153</p><p>nct_number: NCT06216301</p><p>sponsor_name: NovoCure GmbH</p><p>study_title: LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer </p>]]></description></item><item><title>G220307-NCT06182397</title><pubDate>Mon, 05 Aug 2024 09:58:40 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g220307-nct06182397</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g220307-nct06182397</guid><description><![CDATA[<p>approval_date: Wed, 31 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06182397?term=NCT06182397&rank=1title:</p><p>ide_number: G220307</p><p>nct_number: NCT06182397</p><p>sponsor_name: Concept Medical Inc.</p><p>study_title: MAGICAL BTK: Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease</p>]]></description></item><item><title>G230182-NCT06432036</title><pubDate>Mon, 05 Aug 2024 09:54:25 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230182-nct06432036</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230182-nct06432036</guid><description><![CDATA[<p>approval_date: Wed, 31 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06432036?term=NCT06432036&rank=1title:</p><p>ide_number: G230182</p><p>nct_number: NCT06432036</p><p>sponsor_name: Jonsson Comprehensive Cancer Center</p><p>study_title: RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open- Label, Prospective, Multi-Center, Phase 1/2 Safety Trial</p>]]></description></item><item><title>G240001-NCT06358508</title><pubDate>Mon, 05 Aug 2024 09:48:53 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g240001-nct06358508</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g240001-nct06358508</guid><description><![CDATA[<p>approval_date: Tue, 30 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06358508?term=NCT06358508&rank=1title:</p><p>ide_number: G240001</p><p>nct_number: NCT06358508</p><p>sponsor_name: OrbusNeich Medical</p><p>study_title: Acute safety and device performance of the Sapphire 3 (⌀ 0.85, 1.0 and 1.25mm) coronary dilatation catheter in the predilatation of Chronic Total Occlusion (CTO) lesions</p>]]></description></item><item><title>G220272-NCT05723926</title><pubDate>Mon, 05 Aug 2024 09:44:49 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g220272-nct05723926</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g220272-nct05723926</guid><description><![CDATA[<p>approval_date: Tue, 30 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05723926?term=NCT05723926&rank=1title:</p><p>ide_number: G220272</p><p>nct_number: NCT05723926</p><p>sponsor_name: Javelin Medical</p><p>study_title: Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation</p>]]></description></item><item><title>G230312-NCT06453642</title><pubDate>Mon, 29 Jul 2024 06:55:31 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230312-nct06453642</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230312-nct06453642</guid><description><![CDATA[<p>approval_date: Wed, 24 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06453642?term=NCT06453642&rank=1title:</p><p>ide_number: G230312</p><p>nct_number: NCT06453642</p><p>sponsor_name: Fluidx Medical Technology, Inc.</p><p>study_title: Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)</p>]]></description></item><item><title>G230099-NCT05831202</title><pubDate>Mon, 29 Jul 2024 06:54:03 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230099-nct05831202</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230099-nct05831202</guid><description><![CDATA[<p>approval_date: Wed, 24 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05831202?term=NCT05831202&rank=1title:</p><p>ide_number: G230099</p><p>nct_number: NCT05831202</p><p>sponsor_name: Galaxy Therapeutics INC</p><p>study_title: SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial</p>]]></description></item><item><title>G230195-NCT06174805</title><pubDate>Mon, 29 Jul 2024 06:52:53 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230195-nct06174805</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230195-nct06174805</guid><description><![CDATA[<p>approval_date: Mon, 22 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06174805title:</p><p>ide_number: G230195</p><p>nct_number: NCT06174805</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy With Lumen-Apposing Metal Stent for Gastric Outlet Obstruction From Malignant Unresectable Disease</p>]]></description></item><item><title>G230236-NCT06264232</title><pubDate>Mon, 29 Jul 2024 06:51:14 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230236-nct06264232</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/g230236-nct06264232</guid><description><![CDATA[<p>approval_date: Tue, 23 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06264232?term=NCT06264232&rank=1title:</p><p>ide_number: G230236</p><p>nct_number: NCT06264232</p><p>sponsor_name: Zeiss Group</p><p>study_title: At Elana 841p</p>]]></description></item><item><title>G240064-NCT06411990</title><pubDate>Mon, 22 Jul 2024 07:10:03 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240064-nct06411990</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240064-nct06411990</guid><description><![CDATA[<p>approval_date: Tue, 16 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06411990title:</p><p>ide_number: G240064</p><p>nct_number: NCT06411990</p><p>sponsor_name: Jonathan Bath</p><p>study_title: Laser In Situ Fenestration for Endovascular Aortic Repair (LIFE) Study</p>]]></description></item><item><title>BB29239-1-NCT05758077</title><pubDate>Tue, 16 Jul 2024 06:12:52 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb29239-1-nct05758077</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb29239-1-nct05758077</guid><description><![CDATA[<p>approval_date: Wed, 03 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05758077?term=NCT05758077&rank=1title:</p><p>ide_number: BB29239</p><p>nct_number: NCT05758077</p><p>sponsor_name: SeaStar Medical</p><p>study_title: A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy</p>]]></description></item><item><title>G230299-NCT06456554</title><pubDate>Tue, 16 Jul 2024 06:11:22 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230299-nct06456554</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230299-nct06456554</guid><description><![CDATA[<p>approval_date: Tue, 09 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06456554?a=1title:</p><p>ide_number: G230299</p><p>nct_number: NCT06456554</p><p>sponsor_name: RTI Surgical</p><p>study_title: Acellular Dermal Matrix Investigation in Breast Reconstruction</p>]]></description></item><item><title>G240043-NCT06377514</title><pubDate>Tue, 16 Jul 2024 06:09:33 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240043-nct06377514</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240043-nct06377514</guid><description><![CDATA[<p>approval_date: Wed, 03 Jul 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06377514title:</p><p>ide_number: G240043</p><p>nct_number: NCT06377514</p><p>sponsor_name: Johnson &#x26; Johnson Surgical Vision, Inc.</p><p>study_title: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens</p>]]></description></item><item><title>G240020-NCT06310031</title><pubDate>Tue, 02 Jul 2024 06:05:07 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240020-nct06310031</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240020-nct06310031</guid><description><![CDATA[<p>approval_date: Fri, 21 Jun 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06310031?term=NCT06310031&rank=1title:</p><p>ide_number: G240020</p><p>nct_number: NCT06310031</p><p>sponsor_name: BrioHealth Solutions, Inc.</p><p>study_title: Request for Medicare Coverage of the BrioHealth Solutions Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial)</p>]]></description></item><item><title>G240065-NCT06137807</title><pubDate>Tue, 25 Jun 2024 06:08:53 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240065-nct06137807</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240065-nct06137807</guid><description><![CDATA[<p>approval_date: Thu, 06 Jun 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06137807title:</p><p>ide_number: G240065</p><p>nct_number: NCT06137807</p><p>sponsor_name: P+F Products + Features USA Inc.</p><p>study_title: A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV Trial</p>]]></description></item><item><title>G230278-NCT06321575</title><pubDate>Tue, 25 Jun 2024 06:07:39 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230278-nct06321575</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230278-nct06321575</guid><description><![CDATA[<p>approval_date: Mon, 17 Jun 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06321575title:</p><p>ide_number: G230278</p><p>nct_number: NCT06321575</p><p>sponsor_name: Avantec Vascular</p><p>study_title: The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy</p>]]></description></item><item><title>G230165-NCT06217081</title><pubDate>Tue, 11 Jun 2024 06:11:42 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230165-nct06217081</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230165-nct06217081</guid><description><![CDATA[<p>approval_date: Tue, 04 Jun 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06217081title:</p><p>ide_number: G230165</p><p>nct_number: NCT06217081</p><p>sponsor_name: 3M</p><p>study_title: A Multi-Center, Prospective, Open-label, Randomized, Non-inferiority Study of 3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Traumatic Lacerations and Surgical Incisions</p>]]></description></item><item><title>G230251-NCT06189313</title><pubDate>Tue, 11 Jun 2024 06:10:28 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230251-nct06189313</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230251-nct06189313</guid><description><![CDATA[<p>approval_date: Tue, 04 Jun 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06189313title:</p><p>ide_number: G230251</p><p>nct_number: NCT06189313</p><p>sponsor_name: Argon Medical Devices</p><p>study_title: A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism</p>]]></description></item><item><title>G230353-NCT06223789</title><pubDate>Tue, 11 Jun 2024 06:08:31 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230353-nct06223789</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230353-nct06223789</guid><description><![CDATA[<p>approval_date: Tue, 28 May 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06223789title:</p><p>ide_number: G230353</p><p>nct_number: NCT06223789</p><p>sponsor_name: Abbott Medical Devices</p><p>study_title: VOLT-AF IDE Clinical Study</p>]]></description></item><item><title>G230288-NCT06132568</title><pubDate>Tue, 28 May 2024 06:01:14 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230288-nct06132568</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230288-nct06132568</guid><description><![CDATA[<p>approval_date: Wed, 22 May 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06132568title:</p><p>ide_number: G230288</p><p>nct_number: NCT06132568</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study</p>]]></description></item><item><title>G230185-NCT06323980</title><pubDate>Tue, 28 May 2024 05:59:54 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230185-nct06323980</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230185-nct06323980</guid><description><![CDATA[<p>approval_date: Wed, 22 May 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06323980title:</p><p>ide_number: G230185</p><p>nct_number: NCT06323980</p><p>sponsor_name: DePuy Orthopaedics</p><p>study_title: Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System</p>]]></description></item><item><title>G230198-NCT06019793</title><pubDate>Tue, 14 May 2024 06:16:27 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230198-nct06019793</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230198-nct06019793</guid><description><![CDATA[<p>approval_date: Wed, 08 May 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06019793?term=NCT06019793&draw=2&rank=1title:</p><p>ide_number: G230198</p><p>nct_number: NCT06019793</p><p>sponsor_name: St. Joseph's Hospital and Medical Center, Phoenix</p><p>study_title: Electrophysiological Recordings from Deep Brain Stimulation Electrodes for Pain, EPR Pain</p>]]></description></item><item><title>G220168-NCT05561127</title><pubDate>Tue, 14 May 2024 06:15:00 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220168-nct05561127</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220168-nct05561127</guid><description><![CDATA[<p>approval_date: Wed, 08 May 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05561127title:</p><p>ide_number: G220168</p><p>nct_number: NCT05561127</p><p>sponsor_name: GIE Medical</p><p>study_title: Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel</p>]]></description></item><item><title>G230197-NCT06253143</title><pubDate>Tue, 30 Apr 2024 06:07:03 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230197-nct06253143</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230197-nct06253143</guid><description><![CDATA[<p>approval_date: Mon, 22 Apr 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06253143title:</p><p>ide_number: G230197</p><p>nct_number: NCT06253143</p><p>sponsor_name: Aquedeon Medical, Inc.</p><p>study_title: Prospective, Multicenter, Historical Control, Pivotal Study of the Aquedeon Medical Duett™ Vascular Graft System for Surgical Treatment of the Thoracic Aorta</p>]]></description></item><item><title>G220165-NCT06211296</title><pubDate>Tue, 23 Apr 2024 06:20:13 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220165-nct06211296</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220165-nct06211296</guid><description><![CDATA[<p>approval_date: Thu, 18 Apr 2024 23:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06211296?term=NCT06211296&rank=1title:</p><p>ide_number: G220165</p><p>nct_number: NCT06211296</p><p>sponsor_name: Pi-cardia</p><p>study_title: A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ Device (The ShortCut™ CAS)</p>]]></description></item><item><title>G220001-NCT05245812</title><pubDate>Tue, 23 Apr 2024 06:18:27 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220001-nct05245812</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220001-nct05245812</guid><description><![CDATA[<p>approval_date: Tue, 16 Apr 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05624918?term=NCT05624918&rank=1title:</p><p>ide_number: G220001</p><p>nct_number: NCT05245812</p><p>sponsor_name: Deborah Farr, MD</p><p>study_title: Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial</p>]]></description></item><item><title>G240005-NCT06311773</title><pubDate>Tue, 23 Apr 2024 06:16:51 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240005-nct06311773</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g240005-nct06311773</guid><description><![CDATA[<p>approval_date: Tue, 16 Apr 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06311773?term=NCT06311773&rank=1title:</p><p>ide_number: G240005</p><p>nct_number: NCT06311773</p><p>sponsor_name: Aveera Medical, Inc.</p><p>study_title: Pivotal Multicenter Trial of the Boomerang™ Catheter for Percutaneous Deep Vein Arterialization (pDVA)</p>]]></description></item><item><title>G220291-NCT05624918</title><pubDate>Tue, 23 Apr 2024 06:14:55 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220291-nct05624918</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220291-nct05624918</guid><description><![CDATA[<p>approval_date: Tue, 16 Apr 2024 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05624918?term=NCT05624918&rank=1title:</p><p>ide_number: G220291</p><p>nct_number: NCT05624918</p><p>sponsor_name: Ashish Manne</p><p>study_title: A Phase II Study of Peri-Operative NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma</p>]]></description></item><item><title>G230252-NCT06190717</title><pubDate>Tue, 16 Apr 2024 06:06:12 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230252-nct06190717</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230252-nct06190717</guid><description><![CDATA[<p>approval_date: Thu, 11 Apr 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06190717title:</p><p>ide_number: G230252</p><p>nct_number: NCT06190717</p><p>sponsor_name: Sonavex, Inc.</p><p>study_title: Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial</p>]]></description></item><item><title>G230190-NCT06212193</title><pubDate>Tue, 16 Apr 2024 06:04:57 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230190-nct06212193</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230190-nct06212193</guid><description><![CDATA[<p>approval_date: Tue, 09 Apr 2024 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06212193title:</p><p>ide_number: G230190</p><p>nct_number: NCT06212193</p><p>sponsor_name: Innoventric LTD</p><p>study_title: Early Feasibility Study (EFS) to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation (TR)</p>]]></description></item><item><title>G230189-NCT06095050</title><pubDate>Tue, 09 Apr 2024 06:12:21 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230189-nct06095050</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230189-nct06095050</guid><description><![CDATA[<p>approval_date: Wed, 03 Apr 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06095050title:</p><p>ide_number: G230189</p><p>nct_number: NCT06095050</p><p>sponsor_name: Brigham and Women's Hospital</p><p>study_title: Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff</p>]]></description></item><item><title>G220009-NCT05614869</title><pubDate>Tue, 09 Apr 2024 06:10:46 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220009-nct05614869</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220009-nct05614869</guid><description><![CDATA[<p>approval_date: Tue, 02 Apr 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05614869title:</p><p>ide_number: G220009</p><p>nct_number: NCT05614869</p><p>sponsor_name: 3M</p><p>study_title: A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 Days</p>]]></description></item><item><title>G230174-NCT06259409</title><pubDate>Tue, 02 Apr 2024 06:04:24 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230174-nct06259409</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230174-nct06259409</guid><description><![CDATA[<p>approval_date: Thu, 28 Mar 2024 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06259409?term=NCT06259409&draw=2&rank=1title:</p><p>ide_number: G230174</p><p>nct_number: NCT06259409</p><p>sponsor_name: Progenerative Medical, Inc</p><p>study_title: A Randomized Clinical Study Evaluating the Safety of Regenn® Negative Pressure Therapy System in Orthopaedic Surgical Wound Management</p>]]></description></item><item><title>G180240-NCT05742906</title><pubDate>Tue, 02 Apr 2024 06:03:04 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g180240-nct05742906</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g180240-nct05742906</guid><description><![CDATA[<p>approval_date: Fri, 08 Mar 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05742906title:</p><p>ide_number: G180240</p><p>nct_number: NCT05742906</p><p>sponsor_name: CorMatrix Cardiovascular, Inc.</p><p>study_title: CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study</p>]]></description></item><item><title>G230202-NCT06193954</title><pubDate>Tue, 12 Mar 2024 06:28:58 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230202-nct06193954</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230202-nct06193954</guid><description><![CDATA[<p>approval_date: Fri, 08 Mar 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06193954title:</p><p>ide_number: G230202</p><p>nct_number: NCT06193954</p><p>sponsor_name: VasoStar, LLC</p><p>study_title: Evaluation of a Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions in Patients With Chronic Angina Refractory to Maximally Tolerated Guideline Directed Medical Therapy</p>]]></description></item><item><title>BB16057-NCT06258447</title><pubDate>Tue, 12 Mar 2024 06:27:09 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb16057-nct06258447</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb16057-nct06258447</guid><description><![CDATA[<p>approval_date: Fri, 08 Mar 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06258447?term=NCT06258447&rank=1title:</p><p>ide_number: BB16057</p><p>nct_number: NCT06258447</p><p>sponsor_name: BioCardia, Inc.</p><p>study_title: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial</p>]]></description></item><item><title>G210047-NCT05916950</title><pubDate>Tue, 12 Mar 2024 06:25:46 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210047-nct05916950</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210047-nct05916950</guid><description><![CDATA[<p>approval_date: Fri, 19 Jan 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05916950title:</p><p>ide_number: G210047</p><p>nct_number: NCT05916950</p><p>sponsor_name: Philips Clinical &#x26; Medical Affairs Global</p><p>study_title: The THOR IDE Study</p>]]></description></item><item><title>G230187-NCT06174103</title><pubDate>Tue, 12 Mar 2024 06:24:18 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230187-nct06174103</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230187-nct06174103</guid><description><![CDATA[<p>approval_date: Mon, 04 Mar 2024 12:04:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06174103title:</p><p>ide_number: G230187</p><p>nct_number: NCT06174103</p><p>sponsor_name: BiVACOR Inc.</p><p>study_title: BiVACOR® Total Artificial Heart Early Feasibility Study</p>]]></description></item><item><title>G220321-NCT05946629</title><pubDate>Tue, 12 Mar 2024 06:22:34 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220321-nct05946629</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220321-nct05946629</guid><description><![CDATA[<p>approval_date: Mon, 04 Mar 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05946629title:</p><p>ide_number: G220321</p><p>nct_number: NCT05946629</p><p>sponsor_name: M.A. Med Alliance S.A.</p><p>study_title: A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels</p>]]></description></item><item><title>G230104-NCT06042725</title><pubDate>Tue, 27 Feb 2024 06:16:29 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230104-nct06042725</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230104-nct06042725</guid><description><![CDATA[<p>approval_date: Thu, 22 Feb 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06042725title:</p><p>ide_number: G230104</p><p>nct_number: NCT06042725</p><p>sponsor_name: Mayo Clinic</p><p>study_title: Phase I Clinical Trial of Bcl2 Inhibitor Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) in t(11;14) Multiple Myeloma</p>]]></description></item><item><title>G210097-1-NCT05058261</title><pubDate>Tue, 27 Feb 2024 06:14:36 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210097-1-nct05058261</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210097-1-nct05058261</guid><description><![CDATA[<p>approval_date: Thu, 22 Feb 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05058261?term=NCT05058261&draw=2&rank=1title:</p><p>ide_number: G210097-1</p><p>nct_number: NCT05058261</p><p>sponsor_name: Olympus Corporation of the Americas</p><p>study_title: HANAROSTENT® Biliary Flap Lasso Stent System</p>]]></description></item><item><title>BB28591-NCT06225050</title><pubDate>Tue, 27 Feb 2024 06:13:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb28591-nct06225050</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb28591-nct06225050</guid><description><![CDATA[<p>approval_date: Thu, 22 Feb 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06225050title:</p><p>ide_number: BB28591</p><p>nct_number: NCT06225050</p><p>sponsor_name: Miltenyi Biomedicine GmbH</p><p>study_title: A Single-center Pilot Study Using TCRα/β and CD45RA Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation in Adults (HAPLO2022)</p>]]></description></item><item><title>G200185-1-NCT04343313</title><pubDate>Tue, 20 Feb 2024 06:14:31 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200185-1-nct04343313</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200185-1-nct04343313</guid><description><![CDATA[<p>approval_date: Tue, 06 Feb 2024 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT04343313?term=NCT04343313&draw=2&rank=1title:</p><p>ide_number: G200185</p><p>nct_number: NCT04343313</p><p>sponsor_name: Half Moon Medical</p><p>study_title: Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation</p>]]></description></item><item><title>G230162-NCT06111469</title><pubDate>Tue, 20 Feb 2024 06:13:03 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230162-nct06111469</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230162-nct06111469</guid><description><![CDATA[<p>approval_date: Tue, 06 Feb 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06111469?term=NCT06111469&draw=2&rank=1title:</p><p>ide_number: G230162</p><p>nct_number: NCT06111469</p><p>sponsor_name: Bard Peripheral Vascular, Inc.</p><p>study_title: A Prospective, Multi-Center, Non-Randomized, SinGle-Arm Study of the BDTM Low ProfILe Vascular Covered Stent in PerIpheral ArTerY Disease (AGILITY)</p>]]></description></item><item><title>G230258-NCT06099730</title><pubDate>Tue, 06 Feb 2024 06:18:39 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230258-nct06099730</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230258-nct06099730</guid><description><![CDATA[<p>approval_date: Wed, 31 Jan 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06099730?term=Safety+and+Effectiveness+of+Pulmonary+Vein+isOLation+And+posterioR+Wall+Ablation+wIth+pulSed+Field+Energy+in+Patients+With+Paroxysmal+and+Persistent+AF&draw=2&rank=1title:</p><p>ide_number: G230258</p><p>nct_number: NCT06099730</p><p>sponsor_name: Massachusetts General Hospital</p><p>study_title: Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF</p>]]></description></item><item><title>G220071-NCT06147336</title><pubDate>Tue, 06 Feb 2024 06:16:39 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220071-nct06147336</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220071-nct06147336</guid><description><![CDATA[<p>approval_date: Tue, 30 Jan 2024 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/study/NCT06147336title:</p><p>ide_number: G220071</p><p>nct_number: NCT06147336</p><p>sponsor_name: Vectorious Medical Technologies Ltd.</p><p>study_title: A Multi-center, National, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System, for Wirelessly Measuring and Monitoring Left Atrial Pressure (Lap) in Patients With Advanced CHF</p>]]></description></item><item><title>G230204-NCT06041594</title><pubDate>Tue, 23 Jan 2024 06:09:43 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230204-nct06041594</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230204-nct06041594</guid><description><![CDATA[<p>approval_date: Fri, 12 Jan 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06041594title:</p><p>ide_number: G230204</p><p>nct_number: NCT06041594</p><p>sponsor_name: Innova Vascular, Inc.</p><p>study_title: Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)</p>]]></description></item><item><title>G230119-NCT05611242</title><pubDate>Tue, 23 Jan 2024 06:07:53 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230119-nct05611242</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230119-nct05611242</guid><description><![CDATA[<p>approval_date: Fri, 12 Jan 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05611242title:</p><p>ide_number: G230119</p><p>nct_number: NCT05611242</p><p>sponsor_name: Mercy Health Ohio</p><p>study_title: Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial</p>]]></description></item><item><title>G210227-NCT05653336</title><pubDate>Tue, 23 Jan 2024 06:06:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210227-nct05653336</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210227-nct05653336</guid><description><![CDATA[<p>approval_date: Fri, 12 Jan 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05653336?term=perqseal&draw=2&rank=2title:</p><p>ide_number: G210227</p><p>nct_number: NCT05653336</p><p>sponsor_name: Vivasure Medical Limited</p><p>study_title: A Multicentre, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the Vivasure PerQseal® Closure Device System When Used to Achieve Haemostasis of Common Femoral Arteriotomies Created by 12 to 22 F Sheaths in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures</p>]]></description></item><item><title>G230212-NCT06029660</title><pubDate>Tue, 23 Jan 2024 06:05:12 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230212-nct06029660</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230212-nct06029660</guid><description><![CDATA[<p>approval_date: Fri, 12 Jan 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06029660title:</p><p>ide_number: G230212</p><p>nct_number: NCT06029660</p><p>sponsor_name: Shape Memory Medical, Inc.</p><p>study_title: AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion</p>]]></description></item><item><title>G220163-NCT05561114</title><pubDate>Wed, 17 Jan 2024 06:29:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220163-nct05561114</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220163-nct05561114</guid><description><![CDATA[<p>approval_date: Fri, 29 Sep 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05561114?term=NCT05561114&rank=1title:</p><p>ide_number: G220163</p><p>nct_number: NCT05561114</p><p>sponsor_name: GIE Medical</p><p>study_title: Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus (PATENT-E) </p>]]></description></item><item><title>G230155-NCT06054867</title><pubDate>Tue, 09 Jan 2024 06:11:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230155-nct06054867</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230155-nct06054867</guid><description><![CDATA[<p>approval_date: Wed, 03 Jan 2024 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06054867title:</p><p>ide_number: G230155</p><p>nct_number: NCT06054867</p><p>sponsor_name: PROCEPT BioRobotics</p><p>study_title: PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System</p>]]></description></item><item><title>G230169-NCT06128174</title><pubDate>Tue, 09 Jan 2024 06:10:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230169-nct06128174</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230169-nct06128174</guid><description><![CDATA[<p>approval_date: Thu, 21 Dec 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06128174title:</p><p>ide_number: G230169</p><p>nct_number: NCT06128174</p><p>sponsor_name: Vivek Reddy</p><p>study_title: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation (LS-PersAFone)</p>]]></description></item><item><title>G230170-NCT06144632</title><pubDate>Tue, 09 Jan 2024 06:09:07 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230170-nct06144632</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230170-nct06144632</guid><description><![CDATA[<p>approval_date: Thu, 21 Dec 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06144632title:</p><p>ide_number: G230170</p><p>nct_number: NCT06144632</p><p>sponsor_name: Biosense Webster, Inc.</p><p>study_title: Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH™ SF Catheter with the TRUPULSE™ Generator for treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (PAF) SmartPulse PAF</p>]]></description></item><item><title>G210026-NCT06150742</title><pubDate>Fri, 22 Dec 2023 09:48:54 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210026-nct06150742</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210026-nct06150742</guid><description><![CDATA[<p>approval_date: Wed, 20 Dec 2023 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06150742?term=NCT06150742&rank=1title:</p><p>ide_number: G210026</p><p>nct_number: NCT06150742</p><p>sponsor_name: AcelRx Pharmaceuticals, Inc.</p><p>study_title: Niyad™</p>]]></description></item><item><title>G230249-NCT06096337</title><pubDate>Fri, 22 Dec 2023 09:47:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230249-nct06096337</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230249-nct06096337</guid><description><![CDATA[<p>approval_date: Wed, 20 Dec 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06096337?term=A%20Prospective%20Randomized%20Multicenter%20Global%20Study%20Comparing%20Pulsed%20Field%20Ablation%20(PFA)%20Versus%20Anti-Arrhythmic%20Drug%20(AAD)%20Therapy%20as%20a%20First%20Line%20Treatment%20for%20Persistent%20Atrial%20Fibrillation&rank=1title:</p><p>ide_number: G230249</p><p>nct_number: NCT06096337</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation</p>]]></description></item><item><title>G230086-NCT06010563</title><pubDate>Tue, 19 Dec 2023 06:08:11 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230086-nct06010563</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230086-nct06010563</guid><description><![CDATA[<p>approval_date: Thu, 14 Dec 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06010563?term=NCT06010563&rank=1title:</p><p>ide_number: G230086</p><p>nct_number: NCT06010563</p><p>sponsor_name: Venus MedTech (HangZhou) Inc.</p><p>study_title: Evaluation of the Performance Of The VenusP-ValveTM System in Patients With Native RVOT Dysfunction</p>]]></description></item><item><title>G230077-NCT05953337</title><pubDate>Tue, 19 Dec 2023 06:06:40 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230077-nct05953337</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230077-nct05953337</guid><description><![CDATA[<p>approval_date: Wed, 13 Dec 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05953337?term=NCT05953337&rank=1title:</p><p>ide_number: G230077</p><p>nct_number: NCT05953337</p><p>sponsor_name: ABK Biomedical</p><p>study_title: Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)</p>]]></description></item><item><title>G190020-NCT05934487</title><pubDate>Tue, 19 Dec 2023 06:05:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g190020-nct05934487</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g190020-nct05934487</guid><description><![CDATA[<p>approval_date: Tue, 12 Dec 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05934487?term=NCT05934487&rank=1title:</p><p>ide_number: G190020</p><p>nct_number: NCT05934487</p><p>sponsor_name: Endotronix, Inc.</p><p>study_title: A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II Heart Failure Patients</p>]]></description></item><item><title>G230245-NCT06134817</title><pubDate>Tue, 19 Dec 2023 06:03:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230245-nct06134817</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230245-nct06134817</guid><description><![CDATA[<p>approval_date: Fri, 08 Dec 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06134817?term=NCT06134817&rank=1title:</p><p>ide_number: G230245</p><p>nct_number: NCT06134817</p><p>sponsor_name: NYU Langone Health</p><p>study_title: Prospective Pilot Study on Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty</p>]]></description></item><item><title>G220276-NCT06071702</title><pubDate>Tue, 12 Dec 2023 06:02:42 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220276-nct06071702</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220276-nct06071702</guid><description><![CDATA[<p>approval_date: Thu, 07 Dec 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06071702?term=NCT06071702&rank=1title:</p><p>ide_number: G220276</p><p>nct_number: NCT06071702</p><p>sponsor_name: Medinol Ltd.</p><p>study_title: IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System</p>]]></description></item><item><title>G210338–NCT05291884</title><pubDate>Tue, 12 Dec 2023 06:00:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210338-nct05291884</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210338-nct05291884</guid><description><![CDATA[<p>approval_date: Thu, 07 Dec 2023 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05291884?term=NCT05291884&rank=1title:</p><p>ide_number: G210338</p><p>nct_number: NCT05291884</p><p>sponsor_name: Abiomed Inc.</p><p>study_title: Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study</p>]]></description></item><item><title>G230209-NCT06059638</title><pubDate>Tue, 12 Dec 2023 05:58:28 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230209-nct06059638</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230209-nct06059638</guid><description><![CDATA[<p>approval_date: Thu, 07 Dec 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06059638?term=NCT06059638&rank=1title:</p><p>ide_number: G230209</p><p>nct_number: NCT06059638</p><p>sponsor_name: Orchestra BioMed, Inc</p><p>study_title: BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treatment</p>]]></description></item><item><title>G220288-NCT06103591</title><pubDate>Tue, 05 Dec 2023 06:32:53 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220288-nct06103591</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220288-nct06103591</guid><description><![CDATA[<p>approval_date: Thu, 30 Nov 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06103591title:</p><p>ide_number: G220288</p><p>nct_number: NCT06103591</p><p>sponsor_name: EmStop Inc</p><p>study_title: Controlled Arterial Protection to Ultimately Remove Embolic Material</p>]]></description></item><item><title>G200311-NCT05999006</title><pubDate>Tue, 05 Dec 2023 06:31:32 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200311-nct05999006</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200311-nct05999006</guid><description><![CDATA[<p>approval_date: Thu, 30 Nov 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05999006title:</p><p>ide_number: G200311</p><p>nct_number: NCT05999006</p><p>sponsor_name: Elios Vision, Inc.</p><p>study_title: A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure</p>]]></description></item><item><title>G230071-NCT06062329</title><pubDate>Tue, 05 Dec 2023 06:29:31 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230071-nct06062329</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230071-nct06062329</guid><description><![CDATA[<p>approval_date: Thu, 30 Nov 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06062329title:</p><p>ide_number: G230071</p><p>nct_number: NCT06062329</p><p>sponsor_name: Imperative Care, Inc.</p><p>study_title: Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism</p>]]></description></item><item><title>G210172-NCT05848284</title><pubDate>Tue, 05 Dec 2023 06:24:54 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210172-nct05848284</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210172-nct05848284</guid><description><![CDATA[<p>approval_date: Thu, 30 Nov 2023 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05848284title:</p><p>ide_number: G210172</p><p>nct_number: NCT05848284</p><p>sponsor_name: VDyne, Inc.</p><p>study_title: Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation</p>]]></description></item><item><title>G230097-NCT06001827</title><pubDate>Tue, 05 Dec 2023 06:23:08 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230097-nct06001827</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230097-nct06001827</guid><description><![CDATA[<p>approval_date: Thu, 30 Nov 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT06001827title:</p><p>ide_number: G230097</p><p>nct_number: NCT06001827</p><p>sponsor_name: VenoStent</p><p>study_title: SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study</p>]]></description></item><item><title>G220303-NCT05683691</title><pubDate>Tue, 05 Dec 2023 06:21:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220303-nct05683691</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220303-nct05683691</guid><description><![CDATA[<p>approval_date: Thu, 12 Oct 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05683691?term=NCT05683691&rank=1title:</p><p>ide_number: G220303</p><p>nct_number: NCT05683691</p><p>sponsor_name: Francis Medical Inc.</p><p>study_title: Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (VAPOR 2)</p>]]></description></item><item><title>G230050-NCT05650658</title><pubDate>Tue, 05 Dec 2023 06:19:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230050-nct05650658</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230050-nct05650658</guid><description><![CDATA[<p>approval_date: Thu, 19 Oct 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05650658title:</p><p>ide_number: G230050</p><p>nct_number: NCT05650658</p><p>sponsor_name: Baylor College of Medicine</p><p>study_title: Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure (HF) With Left Ventricular Ejection Fraction (LVEF) ≥ 50% and With Either a Wide QRS Complex (>130 ms) or With/Anticipated >40% Pacing Randomized Clinical Trial</p>]]></description></item><item><title>G230085-NCT05848232</title><pubDate>Tue, 05 Dec 2023 06:17:42 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230085-nct05848232</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230085-nct05848232</guid><description><![CDATA[<p>approval_date: Mon, 20 Nov 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05848232title:</p><p>ide_number: G230085</p><p>nct_number: NCT05848232</p><p>sponsor_name: ReFlow Medical, Inc.</p><p>study_title: A Prospective Single-Arm Multicenter Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions</p>]]></description></item><item><title>G220231-NCT05983757</title><pubDate>Mon, 20 Nov 2023 06:35:00 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220231-nct05983757</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220231-nct05983757</guid><description><![CDATA[<p>approval_date: Thu, 16 Nov 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05983757?term=A%20Phase%20III,%20Randomized,%20Multicenter,%20Investigational,%20Open%20Label%20Clinical%20Trial%20That%20Will%20Examine%20Whether%20Treatment%20With%20Endovascular%20Thrombectomy%20is%20Superior%20to%20Standard%20Medical%20Therapy%20Alone%20in%20Patients%20Who%20Suffer%20a%20Distal%20Medium%20Vessel%20Occlusion%20Ischemic%20Strokes.&rank=1title:</p><p>ide_number: G220231</p><p>nct_number: NCT05983757</p><p>sponsor_name: Raul Nogueira</p><p>study_title: A Phase III, Randomized, Multicenter, Investigational, Open Label Clinical Trial That Will Examine Whether Treatment With Endovascular Thrombectomy is Superior to Standard Medical Therapy Alone in Patients Who Suffer a Distal Medium Vessel Occlusion Ischemic Strokes.</p>]]></description></item><item><title>G220209-NCT04115826</title><pubDate>Mon, 20 Nov 2023 06:33:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220209-nct04115826</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220209-nct04115826</guid><description><![CDATA[<p>approval_date: Thu, 09 Nov 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT04115826?term=NCT04115826&rank=1title:</p><p>ide_number: G220209</p><p>nct_number: NCT04115826</p><p>sponsor_name: University of Colorado, Denver</p><p>study_title: Per-oral Pancreatoscopy-guided Lithotripsy vs. Extracorporeal Shock Wave Lithotripsy in Chronic Pancreatitis</p>]]></description></item><item><title>G230138-NCT06010147</title><pubDate>Mon, 20 Nov 2023 06:31:31 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230138-nct06010147</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230138-nct06010147</guid><description><![CDATA[<p>approval_date: Thu, 09 Nov 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06010147?term=NCT06010147&rank=1title:</p><p>ide_number: G230138</p><p>nct_number: NCT06010147</p><p>sponsor_name: Sealonix, Inc. </p><p>study_title: PramStat Sealant Patch</p>]]></description></item><item><title>G230172-NCT05966662</title><pubDate>Mon, 20 Nov 2023 06:30:02 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230172-nct05966662</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230172-nct05966662</guid><description><![CDATA[<p>approval_date: Thu, 09 Nov 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05966662?term=NCT05966662&rank=1title:</p><p>ide_number: G230172</p><p>nct_number: NCT05966662</p><p>sponsor_name: Shockwave Medical, Inc.</p><p>study_title: Prospective, Multicenter, Single-Arm IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD Duo Study)</p>]]></description></item><item><title>G230124-NCT06056557</title><pubDate>Mon, 20 Nov 2023 06:25:30 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230124-nct06056557</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230124-nct06056557</guid><description><![CDATA[<p>approval_date: Thu, 09 Nov 2023 09:07:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT06056557?term=NCT06056557&rank=1title:</p><p>ide_number: G230124</p><p>nct_number: NCT06056557</p><p>sponsor_name: Vivek Reddy</p><p>study_title: Versatility of a Circular Multielectrode Catheter in the Individualized Recognition &#x26; Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy</p>]]></description></item><item><title>G220289-NCT05866419</title><pubDate>Tue, 07 Nov 2023 06:03:43 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220289-nct05866419</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220289-nct05866419</guid><description><![CDATA[<p>approval_date: Thu, 02 Nov 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05866419?term=NCT05866419&rank=1title:</p><p>ide_number: G220289</p><p>nct_number: NCT05866419</p><p>sponsor_name: Alcyone Therapeutics, Inc.</p><p>study_title: Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and DElivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar PunctuRE Trial (PIERRE)</p>]]></description></item><item><title>G230034-NCT05800743</title><pubDate>Tue, 07 Nov 2023 06:02:21 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230034-nct05800743</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230034-nct05800743</guid><description><![CDATA[<p>approval_date: Thu, 02 Nov 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05800743?term=NCT05800743&rank=1title:</p><p>ide_number: G230034</p><p>nct_number: NCT05800743</p><p>sponsor_name: W.L.Gore &#x26; Associates</p><p>study_title: Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta</p>]]></description></item><item><title>G220138-NCT03796468</title><pubDate>Tue, 07 Nov 2023 06:00:59 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220138-nct03796468</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220138-nct03796468</guid><description><![CDATA[<p>approval_date: Thu, 02 Nov 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT03796468?term=NCT03796468&rank=1title:</p><p>ide_number: G220138</p><p>nct_number: NCT03796468</p><p>sponsor_name: University Hospital, Montpellier</p><p>study_title: Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke with Minor Symptoms (NIHSS &#x3C; 6) in Patients Last Seen Well &#x3C; 24 Hours – Minor Stroke Therapy Evaluation (IN EXTREMIS - MOSTE)</p>]]></description></item><item><title>G230105-NCT05900037</title><pubDate>Tue, 07 Nov 2023 05:59:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230105-nct05900037</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230105-nct05900037</guid><description><![CDATA[<p>approval_date: Tue, 24 Oct 2023 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05900037?term=NCT05900037&rank=1title:</p><p>ide_number: G230105</p><p>nct_number: NCT05900037</p><p>sponsor_name: GATT Technologies BV</p><p>study_title: A Prospective, Multicenter, Randomized Clinical Investigation Evaluating GATT-Patch for Hemostasis During Minimally Invasive Liver and Gallbladder Surgery</p>]]></description></item><item><title>G220318-NCT05818150</title><pubDate>Tue, 07 Nov 2023 05:58:16 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220318-nct05818150</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220318-nct05818150</guid><description><![CDATA[<p>approval_date: Fri, 20 Oct 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05818150?term=NCT05818150&rank=1title:</p><p>ide_number: G220318</p><p>nct_number: NCT05818150</p><p>sponsor_name: Merit Medical Systems, Inc.</p><p>study_title: GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)</p>]]></description></item><item><title>G230039-NCT05987241</title><pubDate>Thu, 02 Nov 2023 06:01:27 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230039-nct05987241</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230039-nct05987241</guid><description><![CDATA[<p>approval_date: Thu, 19 Oct 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05987241?term=MODERN&rank=4title:</p><p>ide_number: G230039</p><p>nct_number: NCT05987241</p><p>sponsor_name: National Cancer Institute (NCI)</p><p>study_title: Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study</p>]]></description></item><item><title>G230011-NCT05820009</title><pubDate>Tue, 17 Oct 2023 06:09:40 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230011-nct05820009</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230011-nct05820009</guid><description><![CDATA[<p>approval_date: Thu, 12 Oct 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05820009?term=NCT05820009&rank=1title:</p><p>ide_number: G230011</p><p>nct_number: NCT05820009</p><p>sponsor_name: W.L.Gore &#x26; Associates</p><p>study_title: GORE® VIABIL® Biliary Endoprosthesis for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis</p>]]></description></item><item><title>G220032-NCT05873816</title><pubDate>Tue, 17 Oct 2023 06:07:53 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220032-nct05873816</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220032-nct05873816</guid><description><![CDATA[<p>approval_date: Thu, 12 Oct 2023 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05873816?term=NCT05873816&rank=1title:</p><p>ide_number: G220032</p><p>nct_number: NCT05873816</p><p>sponsor_name: Protembis GmbH</p><p>study_title: The PROTEMBO Trial</p>]]></description></item><item><title>G230084-NCT05836987</title><pubDate>Tue, 26 Sep 2023 14:12:31 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230084-nct05836987</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230084-nct05836987</guid><description><![CDATA[<p>approval_date: Thu, 21 Sep 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05836987title:</p><p>ide_number: G230084</p><p>nct_number: NCT05836987</p><p>sponsor_name: Johns Hopkins University</p><p>study_title: The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation (REACT-AF)</p>]]></description></item><item><title>G220305-NCT05998018</title><pubDate>Tue, 26 Sep 2023 14:11:15 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220305-nct05998018</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220305-nct05998018</guid><description><![CDATA[<p>approval_date: Thu, 21 Sep 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05998018title:</p><p>ide_number: G220305</p><p>nct_number: NCT05998018</p><p>sponsor_name: Stimdia Medical Inc.</p><p>study_title: Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients (ReInvigorate)</p>]]></description></item><item><title>G220264-NCT05913908</title><pubDate>Tue, 19 Sep 2023 06:50:52 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220264-nct05913908</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220264-nct05913908</guid><description><![CDATA[<p>approval_date: Thu, 14 Sep 2023 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05913908?term=NCT05913908&draw=2&rank=1title:</p><p>ide_number: G220264</p><p>nct_number: NCT05913908</p><p>sponsor_name: CroiValve Limited</p><p>study_title: EFS of the DUO System for Tricuspid Regurgitation (TANDEM II) (TANDEM II)</p>]]></description></item><item><title>G230072-NCT05985304</title><pubDate>Tue, 19 Sep 2023 06:48:27 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230072-nct05985304</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230072-nct05985304</guid><description><![CDATA[<p>approval_date: Thu, 14 Sep 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05985304?term=NCT05985304&draw=2&rank=1title:</p><p>ide_number: G230072</p><p>nct_number: NCT05985304</p><p>sponsor_name: Sierra Clinical Services LLC</p><p>study_title: Clinical trial to investigate the safety and effectiveness of a hydrophilic EMV toric lens RAO210T in the correction of aphakia and post-operative corneal astigmatism</p>]]></description></item><item><title>G210059-NCT05529654</title><pubDate>Tue, 12 Sep 2023 06:18:28 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210059-nct05529654</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210059-nct05529654</guid><description><![CDATA[<p>approval_date: Fri, 08 Sep 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05529654title:</p><p>ide_number: G210059</p><p>nct_number: NCT05529654</p><p>sponsor_name: Abiomed Inc.</p><p>study_title: IMpella-Protected cArdiaC Surgery Trial (IMPACT) (IMPACT)</p>]]></description></item><item><title>G210107-NCT05908331</title><pubDate>Tue, 12 Sep 2023 06:17:12 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210107-nct05908331</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210107-nct05908331</guid><description><![CDATA[<p>approval_date: Fri, 08 Sep 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05908331?lupd_s=06%2F05%2F2023title:</p><p>ide_number: G210107</p><p>nct_number: NCT05908331</p><p>sponsor_name: Concept Medical Inc.</p><p>study_title: A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis</p>]]></description></item><item><title>G190234-NCT05988411</title><pubDate>Tue, 12 Sep 2023 06:15:48 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g190234-nct05988411</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g190234-nct05988411</guid><description><![CDATA[<p>approval_date: Tue, 05 Sep 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05988411title:</p><p>ide_number: G190234</p><p>nct_number: NCT05988411</p><p>sponsor_name: Vivek Reddy</p><p>study_title: ULTRASOUND-BASED RENAL SYMPATHETIC DENERVATION AS ADJUNCTIVE UPSTREAM THERAPY DURING ATRIAL FIBRILLATION – REDO ABLATION PROCEDURES: A Pilot Study</p>]]></description></item><item><title>G210110-NCT04875429</title><pubDate>Tue, 12 Sep 2023 06:14:10 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210110-nct04875429</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g210110-nct04875429</guid><description><![CDATA[<p>approval_date: Tue, 05 Sep 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT04875429title:</p><p>ide_number: G210110</p><p>nct_number: NCT04875429</p><p>sponsor_name: Cook Research Incorporated</p><p>study_title: Zenith® Fenestrated+ Endovascular Graft Clinical Study</p>]]></description></item><item><title>G220015-NCT05884125</title><pubDate>Tue, 12 Sep 2023 06:12:42 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220015-nct05884125</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220015-nct05884125</guid><description><![CDATA[<p>approval_date: Tue, 05 Sep 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05884125?term=PHINEST&draw=2&rank=2title:</p><p>ide_number: G220015</p><p>nct_number: NCT05884125</p><p>sponsor_name: Checkpoint Surgical Inc.</p><p>study_title: Promoting Healing of Injured Nerves with Electrical Stimulation Therapy [PHINEST]</p>]]></description></item><item><title>BB16956-NCT03752827</title><pubDate>Wed, 30 Aug 2023 07:46:23 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb16956-nct03752827</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb16956-nct03752827</guid><description><![CDATA[<p>approval_date: Thu, 24 Aug 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT03752827title:</p><p>ide_number: BB16956</p><p>nct_number: NCT03752827</p><p>sponsor_name: InGeneron, Inc.</p><p>study_title: Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears</p>]]></description></item><item><title>G220113-NCT05881278</title><pubDate>Wed, 30 Aug 2023 07:45:00 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220113-nct05881278</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220113-nct05881278</guid><description><![CDATA[<p>approval_date: Thu, 24 Aug 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05881278?lupd_s=05%2F20%2F2023title:</p><p>ide_number: G220113</p><p>nct_number: NCT05881278</p><p>sponsor_name: XVIVO Perfusion, Inc.</p><p>study_title: XVIVO Heart Preservation System (XHPS) with Supplemented XVIVO Heart Solution (SXHS)</p>]]></description></item><item><title>BB27066-NCT04990128</title><pubDate>Wed, 30 Aug 2023 07:43:34 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb27066-nct04990128</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb27066-nct04990128</guid><description><![CDATA[<p>approval_date: Thu, 24 Aug 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT04990128title:</p><p>ide_number: BB27066</p><p>nct_number: NCT04990128</p><p>sponsor_name: The Cleveland Clinic</p><p>study_title: Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis</p>]]></description></item><item><title>G230027-NCT05907564</title><pubDate>Tue, 15 Aug 2023 06:09:42 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230027-nct05907564</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230027-nct05907564</guid><description><![CDATA[<p>approval_date: Thu, 10 Aug 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05907564?lupd_s=06%2F24%2F2022title:</p><p>ide_number: G230027</p><p>nct_number: NCT05907564</p><p>sponsor_name: Inquis Medical, Inc.</p><p>study_title: Treatment of Acute Pulmonary Embolism with the Inquis Medical Thrombectomy System</p>]]></description></item><item><title>BB28705-NCT05641844</title><pubDate>Tue, 15 Aug 2023 06:08:01 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb28705-nct05641844</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/bb28705-nct05641844</guid><description><![CDATA[<p>approval_date: Thu, 10 Aug 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05641844?term=NCT05641844&draw=2&rank=1title:</p><p>ide_number: 28705/3</p><p>nct_number: NCT05641844</p><p>sponsor_name: RedDress Ltd.</p><p>study_title: An Open Label, Randomized Controlled Study, Evaluating the Safety of RD2 Ver.02 For the Management of Anal Fistulas</p>]]></description></item><item><title>G230112-NCT05905835</title><pubDate>Tue, 15 Aug 2023 06:06:14 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230112-nct05905835</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230112-nct05905835</guid><description><![CDATA[<p>approval_date: Tue, 08 Aug 2023 11:00:07 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05905835title:</p><p>ide_number: G230112</p><p>nct_number: NCT05905835</p><p>sponsor_name: Synaptic Medical Corporation </p><p>study_title: Treatment of PAF With the Synaptic System (Sensation)</p>]]></description></item><item><title>G230015-NCT05845710</title><pubDate>Tue, 01 Aug 2023 06:17:21 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230015-nct05845710</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230015-nct05845710</guid><description><![CDATA[<p>approval_date: Thu, 27 Jul 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05845710?term=NCT05845710&rank=1title:</p><p>ide_number: G230015</p><p>nct_number: NCT05845710</p><p>sponsor_name: Contego Medical, Inc.</p><p>study_title: Neuroguard IEP® Direct 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP® Direct System)</p>]]></description></item><item><title>G220190-NCT05839730</title><pubDate>Tue, 01 Aug 2023 06:15:43 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220190-nct05839730</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220190-nct05839730</guid><description><![CDATA[<p>approval_date: Thu, 27 Jul 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05839730?term=NCT05839730&rank=1title:</p><p>ide_number: G220190</p><p>nct_number: NCT05839730</p><p>sponsor_name: Medtronic Cardiac Rhythm and Heart Failure</p><p>study_title: Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction (FIRE-HFpEF)</p>]]></description></item><item><title>G220275-NCT05712161</title><pubDate>Tue, 25 Jul 2023 06:18:48 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220275-nct05712161</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220275-nct05712161</guid><description><![CDATA[<p>approval_date: Thu, 20 Jul 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05712161title:</p><p>ide_number: G220275</p><p>nct_number: NCT05712161</p><p>sponsor_name: Anteris Technologies Ltd.</p><p>study_title: Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study</p>]]></description></item><item><title>G220149-NCT05506449</title><pubDate>Tue, 25 Jul 2023 06:17:07 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220149-nct05506449</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220149-nct05506449</guid><description><![CDATA[<p>approval_date: Thu, 20 Jul 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05506449title:</p><p>ide_number: G220149</p><p>nct_number: NCT05506449</p><p>sponsor_name: Abiomed Inc.</p><p>study_title: RECOVER IV Trial</p>]]></description></item><item><title>G200294-NCT05677100</title><pubDate>Tue, 25 Jul 2023 06:15:46 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200294-nct05677100</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g200294-nct05677100</guid><description><![CDATA[<p>approval_date: Thu, 20 Jul 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/study/NCT05677100?term=NCT05677100&rank=1&tab=tabletitle:</p><p>ide_number: G200294</p><p>nct_number: NCT05677100</p><p>sponsor_name: Procyrion</p><p>study_title: DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure</p>]]></description></item><item><title>G230001-NCT05714501</title><pubDate>Tue, 18 Jul 2023 13:28:40 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230001-nct05714501</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230001-nct05714501</guid><description><![CDATA[<p>approval_date: Thu, 13 Jul 2023 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05714501title:</p><p>ide_number: G230001</p><p>nct_number: NCT05714501</p><p>sponsor_name: Perfuze</p><p>study_title: Millipede AspiRation for Revascularization in Stroke Study (MARRS)</p>]]></description></item><item><title>G220229-NCT05675865</title><pubDate>Tue, 18 Jul 2023 13:04:38 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220229-nct05675865</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220229-nct05675865</guid><description><![CDATA[<p>approval_date: Thu, 13 Jul 2023 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05675865title:</p><p>ide_number: G220229</p><p>nct_number: NCT05675865</p><p>sponsor_name: Adagio Medical</p><p>study_title: Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS) (FULCRUM-VT)</p>]]></description></item><item><title>G220128-NCT05746325</title><pubDate>Mon, 03 Jul 2023 07:16:54 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220128-nct05746325</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220128-nct05746325</guid><description><![CDATA[<p>approval_date: Thu, 29 Jun 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05746325?term=Pilot+Feasibility+Study+of+Tumor+Treating+Fields+in+Treatment+of+Leptomeningeal+Metastases+From+Breast+Carcinoma+Involving+the+Spine&draw=2&rank=1title:</p><p>ide_number: G220128</p><p>nct_number: NCT05746325</p><p>sponsor_name: Mayo Clinic</p><p>study_title: Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine</p>]]></description></item><item><title>G220277-NCT05758545</title><pubDate>Mon, 03 Jul 2023 07:15:16 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220277-nct05758545</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220277-nct05758545</guid><description><![CDATA[<p>approval_date: Tue, 20 Jun 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://classic.clinicaltrials.gov/ct2/show/NCT05758545title:</p><p>ide_number: G220277</p><p>nct_number: NCT05758545</p><p>sponsor_name: Piomic Medical</p><p>study_title: Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial</p>]]></description></item><item><title>G230008-NCT05820087</title><pubDate>Tue, 20 Jun 2023 09:26:47 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230008-nct05820087</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230008-nct05820087</guid><description><![CDATA[<p>approval_date: Thu, 15 Jun 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05820087?term=NCT05820087&draw=2&rank=1title:</p><p>ide_number: G230008</p><p>nct_number: NCT05820087</p><p>sponsor_name: HistoSonics, Inc.</p><p>study_title: The HistoSonics Edison System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY US)</p>]]></description></item><item><title>G220298-NCT05711316</title><pubDate>Tue, 20 Jun 2023 09:25:30 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220298-nct05711316</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220298-nct05711316</guid><description><![CDATA[<p>approval_date: Thu, 15 Jun 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05711316?term=NCT05711316&draw=2&rank=1title:</p><p>ide_number: G220298</p><p>nct_number: NCT05711316</p><p>sponsor_name: Bard Peripheral Vascular, Inc.</p><p>study_title: Liverty™ TIPS Stent Graft</p>]]></description></item><item><title>G230056–NCT05821426</title><pubDate>Tue, 20 Jun 2023 09:24:31 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230056-nct05821426</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230056-nct05821426</guid><description><![CDATA[<p>approval_date: Thu, 15 Jun 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05821426?term=NCT05821426&draw=2&rank=1title:</p><p>ide_number: G230056</p><p>nct_number: NCT05821426</p><p>sponsor_name: Magneto Thrombectomy Solutions</p><p>study_title: eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects with Acute Pulmonary Embolism</p>]]></description></item><item><title>G220300-NCT05858905</title><pubDate>Tue, 20 Jun 2023 09:23:10 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220300-nct05858905</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220300-nct05858905</guid><description><![CDATA[<p>approval_date: Thu, 15 Jun 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05858905title:</p><p>ide_number: G220300</p><p>nct_number: NCT05858905</p><p>sponsor_name: Shockwave Medical</p><p>study_title: Shockwave Intravascular Lithotripsy System with the Shockwave Mini S Peripheral IVL Catheter</p>]]></description></item><item><title>G220284-NCT05763407</title><pubDate>Tue, 13 Jun 2023 06:14:51 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220284-nct05763407</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220284-nct05763407</guid><description><![CDATA[<p>approval_date: Thu, 08 Jun 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05763407title:</p><p>ide_number: G220284</p><p>nct_number: NCT05763407</p><p>sponsor_name: Foundry Innovation &#x26; Research 1, Limited (FIRE1)</p><p>study_title: Early Feasibility Study of the FIRE1™ System in Heart Failure Patients</p>]]></description></item><item><title>G220208-NCT05462145</title><pubDate>Tue, 30 May 2023 11:22:08 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220208-nct05462145</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220208-nct05462145</guid><description><![CDATA[<p>approval_date: Thu, 18 May 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05462145title:</p><p>ide_number: G220208</p><p>nct_number: NCT05462145</p><p>sponsor_name: Kardium Inc.</p><p>study_title: A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation</p>]]></description></item><item><title>G160013-NCT05710042</title><pubDate>Tue, 30 May 2023 11:20:53 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g160013-nct05710042</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g160013-nct05710042</guid><description><![CDATA[<p>approval_date: Thu, 18 May 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05710042title:</p><p>ide_number: G160013</p><p>nct_number: NCT05710042</p><p>sponsor_name: BioVentrix</p><p>study_title: Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms ALIVE-EA (American Less Invasive Ventricular Enhancement-Expanded Access</p>]]></description></item><item><title>G230037-NCT05570916</title><pubDate>Tue, 23 May 2023 06:08:15 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230037-nct05570916</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g230037-nct05570916</guid><description><![CDATA[<p>approval_date: Thu, 18 May 2023 10:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05570916title:</p><p>ide_number: G230037</p><p>nct_number: NCT05570916</p><p>sponsor_name: ZSX Medical LLC</p><p>study_title: Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) Safety &#x26; Efficacy in Hysterectomy</p>]]></description></item><item><title>G220255-NCT05673018</title><pubDate>Tue, 23 May 2023 06:06:57 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220255-nct05673018</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220255-nct05673018</guid><description><![CDATA[<p>approval_date: Thu, 18 May 2023 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05673018title:</p><p>ide_number: G220255</p><p>nct_number: NCT05673018</p><p>sponsor_name: GRAIL</p><p>study_title: Multi-Cancer Early Detection - Real-World Evidence Program in the Medicare Population</p>]]></description></item><item><title>G220237-NCT04280029</title><pubDate>Tue, 23 May 2023 06:05:36 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220237-nct04280029</link><guid>https://www.cms.gov//medicare/coverage/investigational-device-exemption-ide-studies/approved/g220237-nct04280029</guid><description><![CDATA[<p>approval_date: Thu, 18 May 2023 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04280029title:</p><p>ide_number: G220237</p><p>nct_number: NCT04280029</p><p>sponsor_name: M.A. Med Alliance S.A.</p><p>study_title: SELUTION SLR™ 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects With In-stent Restenosis</p>]]></description></item><item><title>G190256-NCT05796908</title><pubDate>Tue, 09 May 2023 06:13:21 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g190256-nct05796908</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g190256-nct05796908</guid><description><![CDATA[<p>approval_date: Thu, 04 May 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05796908title:</p><p>ide_number: G190256</p><p>nct_number: NCT05796908</p><p>sponsor_name: Aptis Medical</p><p>study_title: A Prospective, Multi-Center, Single-Arm Clinical Trial of the Safety and Effectiveness of the Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders</p>]]></description></item><item><title>G220046-NCT05295628</title><pubDate>Tue, 09 May 2023 06:12:20 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220046-nct05295628</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220046-nct05295628</guid><description><![CDATA[<p>approval_date: Thu, 04 May 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05295628title:</p><p>ide_number: G220046</p><p>nct_number: NCT05295628</p><p>sponsor_name: Innovative Cardiovascular Solutions</p><p>study_title: A Prospective, Randomized, Multicenter Evaluation of the Safety and Effectiveness of the EMBLOK Embolic Protection System During Transcatheter Aortic Valve Replacement</p>]]></description></item><item><title>G220162-NCT05477147</title><pubDate>Tue, 02 May 2023 11:29:00 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220162-nct05477147</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220162-nct05477147</guid><description><![CDATA[<p>approval_date: Fri, 28 Apr 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05477147title:</p><p>ide_number: G220162</p><p>nct_number: NCT05477147</p><p>sponsor_name: Volta Medical</p><p>study_title: Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion</p>]]></description></item><item><title>G210243-NCT05357378</title><pubDate>Tue, 25 Apr 2023 06:25:50 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210243-nct05357378</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210243-nct05357378</guid><description><![CDATA[<p>approval_date: Thu, 20 Apr 2023 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05357378?term=NCT05357378&draw=2&rank=1title:</p><p>ide_number: G210243</p><p>nct_number: NCT05357378</p><p>sponsor_name: Hip Innovation Technology</p><p>study_title: Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study</p>]]></description></item><item><title>G220319-NCT05720039</title><pubDate>Tue, 25 Apr 2023 06:24:25 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220319-nct05720039</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220319-nct05720039</guid><description><![CDATA[<p>approval_date: Thu, 20 Apr 2023 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05720039title:</p><p>ide_number: G220319</p><p>nct_number: NCT05720039</p><p>sponsor_name: Intuitive Surgical</p><p>study_title: A Prospective, Multicenter Randomized Controlled Trial (RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures</p>]]></description></item><item><title>G220308-NCT05727059</title><pubDate>Tue, 25 Apr 2023 06:23:20 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220308-nct05727059</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220308-nct05727059</guid><description><![CDATA[<p>approval_date: Thu, 20 Apr 2023 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05727059?term=NCT05727059&draw=2&rank=1title:</p><p>ide_number: G220308</p><p>nct_number: NCT05727059</p><p>sponsor_name: Magenta Medical Ltd.</p><p>study_title: Early Feasibility Study (EFS) of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions</p>]]></description></item><item><title>G210378-NCT04701684</title><pubDate>Tue, 18 Apr 2023 06:20:44 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210378-nct04701684</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210378-nct04701684</guid><description><![CDATA[<p>approval_date: Thu, 13 Apr 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04701684?term=NCT04701684&draw=2&rank=1title:</p><p>ide_number: G210378</p><p>nct_number: NCT04701684</p><p>sponsor_name: Philips Clinical &#x26; Medical Affairs Global</p><p>study_title: WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)</p>]]></description></item><item><title>G200217-NCT04605913</title><pubDate>Tue, 18 Apr 2023 06:19:19 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g200217-nct04605913</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g200217-nct04605913</guid><description><![CDATA[<p>approval_date: Thu, 13 Apr 2023 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04605913?term=NCT04605913&draw=1&rank=1title:</p><p>ide_number: G200217</p><p>nct_number: NCT04605913</p><p>sponsor_name: Mayo Clinic</p><p>study_title: A Phase I/Ib Pilot Trial, Single Arm, Open Label, of Protein-Bound Paclitaxel, Cisplatin, and Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) in Patient With Metastatic Pancreatic Adenocarcinoma</p>]]></description></item><item><title>G220177-NCT05765175</title><pubDate>Tue, 18 Apr 2023 06:18:07 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220177-nct05765175</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220177-nct05765175</guid><description><![CDATA[<p>approval_date: Thu, 13 Apr 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05765175?term=NCT05765175&draw=2&rank=1title:</p><p>ide_number: G220177</p><p>nct_number: NCT05765175</p><p>sponsor_name: Varian, a Siemens Healthineers Company</p><p>study_title: Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)</p>]]></description></item><item><title>G220115-NCT05537753</title><pubDate>Tue, 11 Apr 2023 06:02:36 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220115-nct05537753</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220115-nct05537753</guid><description><![CDATA[<p>approval_date: Thu, 06 Apr 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05537753title:</p><p>ide_number: G220115</p><p>nct_number: NCT05537753</p><p>sponsor_name: Encore Medical Inc.</p><p>study_title: Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial</p>]]></description></item><item><title>G210103-2-NCT04905017</title><pubDate>Tue, 04 Apr 2023 06:05:05 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210103-2-nct04905017</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210103-2-nct04905017</guid><description><![CDATA[<p>approval_date: Fri, 31 Mar 2023 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04905017title:</p><p>ide_number: G210103</p><p>nct_number: NCT04905017</p><p>sponsor_name: Trisol Medical</p><p>study_title: Early Feasibility Study of the Trisol System</p>]]></description></item><item><title>G180033-NCT05686317</title><pubDate>Tue, 04 Apr 2023 06:03:57 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g180033-nct05686317</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g180033-nct05686317</guid><description><![CDATA[<p>approval_date: Fri, 31 Mar 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05686317title:</p><p>ide_number: G180033</p><p>nct_number: NCT05686317</p><p>sponsor_name: Edwards Lifesciences</p><p>study_title: A Randomized, Sham-controlled Trial of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)</p>]]></description></item><item><title>G210118-NCT05740176</title><pubDate>Tue, 04 Apr 2023 06:02:25 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210118-nct05740176</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210118-nct05740176</guid><description><![CDATA[<p>approval_date: Fri, 31 Mar 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT05740176title:</p><p>ide_number: G210118</p><p>nct_number: NCT05740176</p><p>sponsor_name: Synergy Spine Solutions</p><p>study_title: A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing the Safety and Effectiveness of the Synergy Disc to Anterior Cervical Discectomy and Fusion in Patients With Two-Level Symptomatic Cervical Degenerative Disc Disease (DDD)</p>]]></description></item><item><title>G220033-NCT05684146</title><pubDate>Tue, 28 Mar 2023 06:05:18 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220033-nct05684146</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220033-nct05684146</guid><description><![CDATA[<p>approval_date: Thu, 23 Mar 2023 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05684146?term=NCT05684146&draw=2&rank=1title:</p><p>ide_number: G220033</p><p>nct_number: NCT05684146</p><p>sponsor_name: Emboline</p><p>study_title: Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device	</p>]]></description></item><item><title>G220281-NCT05679674</title><pubDate>Tue, 21 Mar 2023 06:07:02 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220281-nct05679674</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220281-nct05679674</guid><description><![CDATA[<p>approval_date: Thu, 16 Mar 2023 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05679674title:</p><p>ide_number: G220281</p><p>nct_number: NCT05679674</p><p>sponsor_name: Baptist Health South Florida</p><p>study_title: Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer</p>]]></description></item><item><title>G220017-NCT05116384</title><pubDate>Tue, 21 Mar 2023 06:05:54 -0400</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220017-nct05116384</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220017-nct05116384</guid><description><![CDATA[<p>approval_date: Thu, 16 Mar 2023 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05116384title:</p><p>ide_number: G220017</p><p>nct_number: NCT05116384</p><p>sponsor_name: Medtronic</p><p>study_title: Symplicity Spyral Renal Denervation System</p>]]></description></item><item><title>G210130-NCT05361941</title><pubDate>Tue, 28 Feb 2023 06:32:25 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210130-nct05361941</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210130-nct05361941</guid><description><![CDATA[<p>approval_date: Fri, 17 Feb 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT05361941?term=NCT05361941&draw=2&rank=1title:</p><p>ide_number: G210130</p><p>nct_number: NCT05361941</p><p>sponsor_name: Elute, Inc.</p><p>study_title: Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities</p>]]></description></item><item><title>G220182-NCT05541016</title><pubDate>Tue, 28 Feb 2023 06:31:14 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220182-nct05541016</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220182-nct05541016</guid><description><![CDATA[<p>approval_date: Fri, 17 Feb 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT05541016?term=NCT05541016&draw=2&rank=1title:</p><p>ide_number: G220182</p><p>nct_number: NCT05541016</p><p>sponsor_name: Mayo Clinic</p><p>study_title: DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy 	</p>]]></description></item><item><title>G220169-NCT05489588</title><pubDate>Tue, 21 Feb 2023 06:02:49 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220169-nct05489588</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220169-nct05489588</guid><description><![CDATA[<p>approval_date: Thu, 19 Jan 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05489588title:</p><p>ide_number: G220169</p><p>nct_number: NCT05489588</p><p>sponsor_name: W.L.Gore &#x26; Associates</p><p>study_title: Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction</p>]]></description></item><item><title>G220057-NCT05339061</title><pubDate>Tue, 17 Jan 2023 06:12:44 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220057-nct05339061</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220057-nct05339061</guid><description><![CDATA[<p>approval_date: Thu, 12 Jan 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05339061title:</p><p>ide_number: G220057</p><p>nct_number: NCT05339061</p><p>sponsor_name: University of California, San Diego</p><p>study_title: A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair</p>]]></description></item><item><title>G220157-NCT05652218</title><pubDate>Tue, 17 Jan 2023 06:11:27 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220157-nct05652218</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220157-nct05652218</guid><description><![CDATA[<p>approval_date: Thu, 12 Jan 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05652218title:</p><p>ide_number: G220157</p><p>nct_number: NCT05652218</p><p>sponsor_name: Inova Health Care Services</p><p>study_title: REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial</p>]]></description></item><item><title>G220147-NCT05554471</title><pubDate>Tue, 17 Jan 2023 06:10:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220147-nct05554471</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220147-nct05554471</guid><description><![CDATA[<p>approval_date: Thu, 12 Jan 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05554471title:</p><p>ide_number: G220147</p><p>nct_number: NCT05554471</p><p>sponsor_name: Cordis Corporation</p><p>study_title: A Multicenter, Prospective, Randomized, Controlled, Open Label Trial to Evaluate the Safety and Efficacy of Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression in Patients Who Have Undergone Endovascular Procedures Utilizing up to 12F Procedural Sheaths</p>]]></description></item><item><title>G180220-NCT03814850</title><pubDate>Tue, 10 Jan 2023 06:05:11 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g180220-nct03814850</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g180220-nct03814850</guid><description><![CDATA[<p>approval_date: Thu, 05 Jan 2023 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03814850title:</p><p>ide_number: G180220</p><p>nct_number: NCT03814850</p><p>sponsor_name: Sebastian Koch</p><p>study_title: Remote Ischemic PreConditioning Provides Neuroprotection: A Phase 2, Single Center, Randomized, Double-Blind, Sham-Controlled, Safety and Efficacy Study Evaluating the Use of Remote Ischemic Preconditioning in Patients Undergoing Endovascular Repair of Brain Aneurysms</p>]]></description></item><item><title>G210245-NCT05195905</title><pubDate>Tue, 03 Jan 2023 09:47:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210245-nct05195905</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g210245-nct05195905</guid><description><![CDATA[<p>approval_date: Thu, 29 Dec 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05195905title:</p><p>ide_number: G210245</p><p>nct_number: NCT05195905</p><p>sponsor_name: Konstantinos Arnaoutakis</p><p>study_title: Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts</p>]]></description></item><item><title>G220093-NCT05478304</title><pubDate>Tue, 03 Jan 2023 09:46:03 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220093-nct05478304</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220093-nct05478304</guid><description><![CDATA[<p>approval_date: Thu, 22 Dec 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05478304title:</p><p>ide_number: G220093</p><p>nct_number: NCT05478304</p><p>sponsor_name: AtriCure, Inc.</p><p>study_title: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial</p>]]></description></item><item><title>G220252-NCT05597891</title><pubDate>Tue, 03 Jan 2023 09:44:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220252-nct05597891</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies/g220252-nct05597891</guid><description><![CDATA[<p>approval_date: Thu, 22 Dec 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT05597891title:</p><p>ide_number: G220252</p><p>nct_number: NCT05597891</p><p>sponsor_name: EndovascularEngineering</p><p>study_title: Viper Catheter System</p>]]></description></item><item><title>G220225-NCT05574959</title><pubDate>Tue, 03 Jan 2023 09:42:52 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220225-nct05574959</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220225-nct05574959</guid><description><![CDATA[<p>approval_date: Fri, 23 Dec 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05574959title:</p><p>ide_number: G220225</p><p>nct_number: NCT05574959</p><p>sponsor_name: Johnson &#x26; Johnson Surgical Vision, Inc.</p><p>study_title: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V</p>]]></description></item><item><title>G220109-NCT05409976</title><pubDate>Tue, 20 Dec 2022 06:44:03 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220109-nct05409976</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220109-nct05409976</guid><description><![CDATA[<p>approval_date: Mon, 19 Dec 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05409976title:</p><p>ide_number: G220109</p><p>nct_number: NCT05409976</p><p>sponsor_name: W.L.Gore &#x26; Associates</p><p>study_title: Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction</p>]]></description></item><item><title>G220061-NCT05541679</title><pubDate>Tue, 20 Dec 2022 06:42:59 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220061-nct05541679</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220061-nct05541679</guid><description><![CDATA[<p>approval_date: Fri, 09 Dec 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05541679?term=Comparison+of+Left+Bundle+Branch+Area+Versus+Right+Ventricular+Septal+Pacing+in+Patients+With+High-degree+Conduction+Disease+After+Transcatheter+Aortic+Valve+Replacement&draw=2&rank=1title:</p><p>ide_number: G220061</p><p>nct_number: NCT05541679</p><p>sponsor_name: Main Line Health</p><p>study_title: Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement</p>]]></description></item><item><title>G200313-NCT05444049</title><pubDate>Tue, 13 Dec 2022 06:21:45 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200313-nct05444049</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200313-nct05444049</guid><description><![CDATA[<p>approval_date: Thu, 08 Dec 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05444049title:</p><p>ide_number: G200313</p><p>nct_number: NCT05444049</p><p>sponsor_name: Neurescue Inc</p><p>study_title: A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest</p>]]></description></item><item><title>G210315-NCT05406622</title><pubDate>Tue, 13 Dec 2022 06:20:22 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210315-nct05406622</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210315-nct05406622</guid><description><![CDATA[<p>approval_date: Thu, 08 Dec 2022 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05406622title:</p><p>ide_number: G210315</p><p>nct_number: NCT05406622</p><p>sponsor_name: REVA Medical, Inc.</p><p>study_title: A Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluating the Safety and Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared With Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions</p>]]></description></item><item><title>G210182-NCT05550571</title><pubDate>Tue, 13 Dec 2022 06:19:15 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210182-nct05550571</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210182-nct05550571</guid><description><![CDATA[<p>approval_date: Thu, 08 Dec 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05550571title:</p><p>ide_number: G210182</p><p>nct_number: NCT05550571</p><p>sponsor_name: Vastrax</p><p>study_title: Treatment of Ruptured Wide-Neck Aneurysms with Nautilus Device Assisted Occlusion (TORNADO)</p>]]></description></item><item><title>BB19519-NCT05565105</title><pubDate>Tue, 13 Dec 2022 06:17:57 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/bb19519-nct05565105</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/bb19519-nct05565105</guid><description><![CDATA[<p>approval_date: Thu, 08 Dec 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05565105title:</p><p>ide_number: BB19519</p><p>nct_number: NCT05565105</p><p>sponsor_name: Baptist Health South Florida</p><p>study_title: A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma</p>]]></description></item><item><title>G220087-NCT05358353</title><pubDate>Tue, 06 Dec 2022 06:06:28 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220087-nct05358353</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220087-nct05358353</guid><description><![CDATA[<p>approval_date: Thu, 01 Dec 2022 11:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05358353title:</p><p>ide_number: G220087</p><p>nct_number: NCT05358353</p><p>sponsor_name: ReFlow Medical, Inc.</p><p>study_title: A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)</p>]]></description></item><item><title>G210325-NCT05385952</title><pubDate>Tue, 22 Nov 2022 06:06:43 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210325-nct05385952</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210325-nct05385952</guid><description><![CDATA[<p>approval_date: Thu, 17 Nov 2022 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05385952?term=NCT05385952&draw=2&rank=1title:</p><p>ide_number: G210325</p><p>nct_number: NCT05385952</p><p>sponsor_name: GATT Technologies BV</p><p>study_title: A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery</p>]]></description></item><item><title>G220165-NCT04952909</title><pubDate>Tue, 22 Nov 2022 06:05:39 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220165-nct04952909</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220165-nct04952909</guid><description><![CDATA[<p>approval_date: Thu, 17 Nov 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04952909title:</p><p>ide_number: G220165</p><p>nct_number: NCT04952909</p><p>sponsor_name: Pi-cardia</p><p>study_title: A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)</p>]]></description></item><item><title>G220004-NCT05531084</title><pubDate>Tue, 22 Nov 2022 06:04:32 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220004-nct05531084</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220004-nct05531084</guid><description><![CDATA[<p>approval_date: Thu, 17 Nov 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05531084?term=NCT05531084&draw=2&rank=1title:</p><p>ide_number: G220004</p><p>nct_number: NCT05531084</p><p>sponsor_name: Jesse Manunga, MD</p><p>study_title: Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms</p>]]></description></item><item><title>G210372-NCT05325242</title><pubDate>Tue, 15 Nov 2022 06:10:28 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210372-nct05325242</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210372-nct05325242</guid><description><![CDATA[<p>approval_date: Wed, 09 Nov 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT05325242title:</p><p>ide_number: G210372</p><p>nct_number: NCT05325242</p><p>sponsor_name: Siddharth Padia, MD</p><p>study_title: Safety and Efficacy of Elbow Artery Embolization (EAE) for the Treatment of Lateral Epicondylitis</p>]]></description></item><item><title>G150210-NCT05425459</title><pubDate>Tue, 15 Nov 2022 06:09:14 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150210-nct05425459</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150210-nct05425459</guid><description><![CDATA[<p>approval_date: Tue, 20 Sep 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05425459title:</p><p>ide_number: G150210</p><p>nct_number: NCT05425459</p><p>sponsor_name: Corvia Medical</p><p>study_title: Responder-HF Trial</p>]]></description></item><item><title>G210321-NCT05248308</title><pubDate>Tue, 08 Nov 2022 06:55:53 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210321-nct05248308</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210321-nct05248308</guid><description><![CDATA[<p>approval_date: Thu, 03 Nov 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05248308title:</p><p>ide_number: G210321</p><p>nct_number: NCT05248308</p><p>sponsor_name: Brigham and Women's Hospital</p><p>study_title: Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain</p>]]></description></item><item><title>G210141-NCT05560763</title><pubDate>Tue, 08 Nov 2022 06:54:53 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210141-nct05560763</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210141-nct05560763</guid><description><![CDATA[<p>approval_date: Thu, 03 Nov 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05560763title:</p><p>ide_number: G210141</p><p>nct_number: NCT05560763</p><p>sponsor_name: Inari Medical</p><p>study_title: FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2</p>]]></description></item><item><title>G210320-NCT05132361</title><pubDate>Tue, 01 Nov 2022 06:04:29 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210320-nct05132361</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210320-nct05132361</guid><description><![CDATA[<p>approval_date: Thu, 27 Oct 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05132361title:</p><p>ide_number: G210320</p><p>nct_number: NCT05132361</p><p>sponsor_name: M.A. Med Alliance S.A.</p><p>study_title: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Efficacy of the SELUTION SLR™ 018 Drug Eluting Balloon in the Treatment of Subjects With Femoropopliteal Artery Lesions</p>]]></description></item><item><title>G220126-NCT05437055</title><pubDate>Tue, 01 Nov 2022 06:03:31 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220126-nct05437055</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220126-nct05437055</guid><description><![CDATA[<p>approval_date: Mon, 24 Oct 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05437055title:</p><p>ide_number: G220126</p><p>nct_number: NCT05437055</p><p>sponsor_name: Penumbra Inc.</p><p>study_title: THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing</p>]]></description></item><item><title>G220102-NCT05372679</title><pubDate>Tue, 18 Oct 2022 06:36:27 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220102-nct05372679</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220102-nct05372679</guid><description><![CDATA[<p>approval_date: Thu, 13 Oct 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05372679title:</p><p>ide_number: G220102</p><p>nct_number: NCT05372679</p><p>sponsor_name: SoniVie Inc.</p><p>study_title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Uncontrolled Stage 2 Hypertension</p>]]></description></item><item><title>G190134-NCT04498026</title><pubDate>Tue, 18 Oct 2022 06:34:12 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190134-nct04498026</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190134-nct04498026</guid><description><![CDATA[<p>approval_date: Thu, 06 Oct 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04498026title:</p><p>ide_number: G190134</p><p>nct_number: NCT04498026</p><p>sponsor_name: Stryker Craniomaxillofacial</p><p>study_title: A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures</p>]]></description></item><item><title>G210212-NCT05268094</title><pubDate>Mon, 29 Aug 2022 10:47:20 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210212-nct05268094</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210212-nct05268094</guid><description><![CDATA[<p>approval_date: Thu, 25 Aug 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05268094title:</p><p>ide_number: G210212</p><p>nct_number: NCT05268094</p><p>sponsor_name: HealthCore-NERI</p><p>study_title: Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)</p>]]></description></item><item><title>G210349-NCT05251363</title><pubDate>Mon, 29 Aug 2022 10:45:54 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210349-nct05251363</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210349-nct05251363</guid><description><![CDATA[<p>approval_date: Thu, 25 Aug 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05251363title:</p><p>ide_number: G210349</p><p>nct_number: NCT05251363</p><p>sponsor_name: Biotronik, Inc.</p><p>study_title: BIOTRONIK Conduction System Pacing With the Solia Lead</p>]]></description></item><item><title>G210241-NCT05364502</title><pubDate>Mon, 29 Aug 2022 10:44:36 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210241-nct05364502</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210241-nct05364502</guid><description><![CDATA[<p>approval_date: Thu, 25 Aug 2022 11:01:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05364502title:</p><p>ide_number: G210241</p><p>nct_number: NCT05364502</p><p>sponsor_name: Instylla, Inc.</p><p>study_title: A Prospective Multicenter Single-Arm Staged Study to Evaluate the Safety and Effectiveness of Embrace™ Hydrogel Embolic For Transcatheter Embolization of Arterial Bleeding in Solid Organs and Peripheral Arteries</p>]]></description></item><item><title>G070038-NCT04595903</title><pubDate>Mon, 29 Aug 2022 10:43:00 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g070038-nct04595903</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g070038-nct04595903</guid><description><![CDATA[<p>approval_date: Thu, 25 Aug 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04595903title:</p><p>ide_number: G070038</p><p>nct_number: NCT04595903</p><p>sponsor_name: Aethlon Medical Inc.</p><p>study_title: Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device</p>]]></description></item><item><title>G210298-NCT05135676</title><pubDate>Mon, 22 Aug 2022 10:29:53 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210298-nct05135676</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210298-nct05135676</guid><description><![CDATA[<p>approval_date: Fri, 12 Aug 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05135676title:</p><p>ide_number: G210298</p><p>nct_number: NCT05135676</p><p>sponsor_name: Jaeb Center for Health Research</p><p>study_title: Time in Glucose Hospital Target (TIGHT) - A Randomized Clinical Trial to Evaluate the Use of CGM to Achieve a Mean Glucose Target of 90 to 130 mg/dL Without Hypoglycemia in Hospitalized Adults With Type 2 Diabetes</p>]]></description></item><item><title>G200132-NCT05364983</title><pubDate>Tue, 16 Aug 2022 16:18:18 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200132-nct05364983</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200132-nct05364983</guid><description><![CDATA[<p>approval_date: Wed, 10 Aug 2022 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05364983title:</p><p>ide_number: G200132</p><p>nct_number: NCT05364983</p><p>sponsor_name: LensGen, Inc.</p><p>study_title: A Prospective, Randomized, Controlled, Double-Masked, Phased, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of the LensGen® Juvene® Intraocular Lens</p>]]></description></item><item><title>G210083-NCT04919980</title><pubDate>Tue, 16 Aug 2022 16:13:35 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210083-nct04919980</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210083-nct04919980</guid><description><![CDATA[<p>approval_date: Wed, 10 Aug 2022 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04919980title:</p><p>ide_number: G210083</p><p>nct_number: NCT04919980</p><p>sponsor_name: Innovalve Bio Medical Ltd.</p><p>study_title: TVMR With the Innovalve System Trial - Early Feasibility Study</p>]]></description></item><item><title>G220079-NCT05443594</title><pubDate>Tue, 16 Aug 2022 16:08:24 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220079-nct05443594</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220079-nct05443594</guid><description><![CDATA[<p>approval_date: Wed, 10 Aug 2022 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05443594title:</p><p>ide_number: G220079</p><p>nct_number: NCT05443594</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation</p>]]></description></item><item><title>G220096-NCT05151172</title><pubDate>Tue, 16 Aug 2022 16:03:54 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220096-nct05151172</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220096-nct05151172</guid><description><![CDATA[<p>approval_date: Wed, 10 Aug 2022 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05151172title:</p><p>ide_number: G220096</p><p>nct_number: NCT05151172</p><p>sponsor_name: Dr. Michael Hill, University of Calgary</p><p>study_title: A Multicentre, Prospective, Randomized, Parallel Group, Open-label Design to Determine the Efficacy and Safety of Endovascular Thrombectomy for Ischemic Stroke Patients With Symptomatic Acute Medium Vessel Intracranial Occlusions</p>]]></description></item><item><title>G200321-NCT04862689</title><pubDate>Tue, 16 Aug 2022 15:46:52 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200321-nct04862689</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200321-nct04862689</guid><description><![CDATA[<p>approval_date: Wed, 10 Aug 2022 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT004862689title:</p><p>ide_number: G200321</p><p>nct_number: NCT04862689</p><p>sponsor_name: Vascular Solutions LLC</p><p>study_title: A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)</p>]]></description></item><item><title>G210237-NCT05150210</title><pubDate>Mon, 08 Aug 2022 06:26:40 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210237-nct05150210</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210237-nct05150210</guid><description><![CDATA[<p>approval_date: Mon, 18 Jul 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05150210title:</p><p>ide_number: G210237</p><p>nct_number: NCT05150210</p><p>sponsor_name: Intuitive Surgical</p><p>study_title: A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Pulmonary Lobectomy and Thymectomy for Benign and Malignant Disease</p>]]></description></item><item><title>G190311-NCT05190978</title><pubDate>Mon, 08 Aug 2022 06:25:06 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190311-nct05190978</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190311-nct05190978</guid><description><![CDATA[<p>approval_date: Mon, 18 Jul 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05190978title:</p><p>ide_number: G190311</p><p>nct_number: NCT05190978</p><p>sponsor_name: University of California, Los Angeles</p><p>study_title: Pre-pectoral Tissue Expander to Implant Breast Reconstruction with and without Mesh Assistance: Multicenter Randomized Controlled Trial</p>]]></description></item><item><title>G130221-NCT02089217</title><pubDate>Tue, 02 Aug 2022 06:09:23 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g130221-nct02089217</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g130221-nct02089217</guid><description><![CDATA[<p>approval_date: Fri, 24 Jun 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02089217title:</p><p>ide_number: G130221</p><p>nct_number: NCT02089217</p><p>sponsor_name: Thomas G. Brott, M.D.</p><p>study_title: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial</p>]]></description></item><item><title>G160156-NCT05313165</title><pubDate>Tue, 02 Aug 2022 06:07:52 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160156-nct05313165</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160156-nct05313165</guid><description><![CDATA[<p>approval_date: Thu, 28 Jul 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05313165?term=NCT05313165&draw=2&rank=1title:</p><p>ide_number: G160156</p><p>nct_number: NCT05313165</p><p>sponsor_name: LimFlow, Inc.</p><p>study_title: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial</p>]]></description></item><item><title>G210342-NCT05055297</title><pubDate>Tue, 02 Aug 2022 06:06:17 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210342-nct05055297</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210342-nct05055297</guid><description><![CDATA[<p>approval_date: Thu, 28 Jul 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05055297?term=NCT05055297&draw=2&rank=1title:</p><p>ide_number: G210342</p><p>nct_number: NCT05055297</p><p>sponsor_name: M.A. Med Alliance S.A.</p><p>study_title: SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)</p>]]></description></item><item><title>G210286-NCT05147571</title><pubDate>Tue, 19 Jul 2022 07:53:14 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210286-nct05147571</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210286-nct05147571</guid><description><![CDATA[<p>approval_date: Tue, 12 Jul 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05147571title:</p><p>ide_number: G210286</p><p>nct_number: NCT05147571</p><p>sponsor_name: NeuroPace</p><p>study_title: RNS® System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study</p>]]></description></item><item><title>G210303-NCT05299606</title><pubDate>Tue, 19 Jul 2022 07:51:56 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210303-nct05299606</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210303-nct05299606</guid><description><![CDATA[<p>approval_date: Tue, 12 Jul 2022 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05299606title:</p><p>ide_number: G210303</p><p>nct_number: NCT05299606</p><p>sponsor_name: Ethicon, Inc.</p><p>study_title: A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic Assisted Bronchoscopy in Subjects with Oligometastatic Tumors in the Lung </p>]]></description></item><item><title>G210365-NCT05291507</title><pubDate>Tue, 19 Jul 2022 07:50:10 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210365-nct05291507</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210365-nct05291507</guid><description><![CDATA[<p>approval_date: Tue, 12 Jul 2022 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05291507title:</p><p>ide_number: G210365</p><p>nct_number: NCT05291507</p><p>sponsor_name: University of Utah</p><p>study_title: A Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System</p>]]></description></item><item><title>G200307-NCT04801225</title><pubDate>Tue, 12 Jul 2022 16:09:26 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200307-nct04801225</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200307-nct04801225</guid><description><![CDATA[<p>approval_date: Fri, 24 Jun 2022 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04801225title:</p><p>ide_number: G200307</p><p>nct_number: NCT04801225</p><p>sponsor_name: Nervive, Inc.</p><p>study_title: Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients</p>]]></description></item><item><title>G210180-NCT05379153</title><pubDate>Tue, 12 Jul 2022 15:59:05 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210180-nct05379153</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210180-nct05379153</guid><description><![CDATA[<p>approval_date: Thu, 23 Jun 2022 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05379153title:</p><p>ide_number: G210180</p><p>nct_number: NCT05379153</p><p>sponsor_name: Alliance for Clinical Trials in Oncology</p><p>study_title: The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors</p>]]></description></item><item><title>G200355-NCT05119842</title><pubDate>Tue, 21 Jun 2022 06:21:23 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200355-nct05119842</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200355-nct05119842</guid><description><![CDATA[<p>approval_date: Thu, 16 Jun 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05119842title:</p><p>ide_number: G200355</p><p>nct_number: NCT05119842</p><p>sponsor_name: APrevent Biotech GmbH</p><p>study_title: Study on the Safety and Effectiveness of APrevent® VOIS Implants for Treatment in Patients With Unilateral Vocal Fold Paralysis (UVFP) - a Two-Part, Open-Label, Non-Randomized Multicenter Study</p>]]></description></item><item><title>G210308-NCT05318092</title><pubDate>Tue, 21 Jun 2022 06:20:11 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210308-nct05318092</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210308-nct05318092</guid><description><![CDATA[<p>approval_date: Thu, 16 Jun 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05318092title:</p><p>ide_number: G210308</p><p>nct_number: NCT05318092</p><p>sponsor_name: Angiodynamics, Inc.</p><p>study_title: Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism</p>]]></description></item><item><title>G200126-NCT05334784</title><pubDate>Tue, 21 Jun 2022 06:18:34 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200126-nct05334784</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200126-nct05334784</guid><description><![CDATA[<p>approval_date: Thu, 16 Jun 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05334784title:</p><p>ide_number: G200126</p><p>nct_number: NCT05334784</p><p>sponsor_name: Abiomed Inc.</p><p>study_title: Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention</p>]]></description></item><item><title>G210165-NCT04176965</title><pubDate>Tue, 07 Jun 2022 06:13:06 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210165-nct04176965</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210165-nct04176965</guid><description><![CDATA[<p>approval_date: Wed, 01 Jun 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04176965title:</p><p>ide_number: G210165</p><p>nct_number: NCT04176965</p><p>sponsor_name: Beaver-Visitec International, Inc.</p><p>study_title: Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL</p>]]></description></item><item><title>G210309-NCT05280093</title><pubDate>Tue, 31 May 2022 06:18:21 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210309-nct05280093</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210309-nct05280093</guid><description><![CDATA[<p>approval_date: Thu, 26 May 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05280093title:</p><p>ide_number: G210309</p><p>nct_number: NCT05280093</p><p>sponsor_name: AtriCure, Inc.</p><p>study_title: Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia</p>]]></description></item><item><title>G220034-NCT05293639</title><pubDate>Tue, 31 May 2022 06:17:03 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220034-nct05293639</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g220034-nct05293639</guid><description><![CDATA[<p>approval_date: Thu, 19 May 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05293639title:</p><p>ide_number: G220034</p><p>nct_number: NCT05293639</p><p>sponsor_name: Biosense Webster, Inc.</p><p>study_title: Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)</p>]]></description></item><item><title>G150104-NCT05010759</title><pubDate>Tue, 10 May 2022 06:21:03 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150104-nct05010759</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150104-nct05010759</guid><description><![CDATA[<p>approval_date: Wed, 04 May 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05010759title:</p><p>ide_number: G150104</p><p>nct_number: NCT05010759</p><p>sponsor_name: MagForce USA</p><p>study_title: Stage 2B of: A Pivotal, Prospective, Three-Stage, Single-Arm Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for a Limited-Volume, Clinically Localized, Intermediate-Risk Prostate Cancer</p>]]></description></item><item><title>G210002-NCT05018650</title><pubDate>Tue, 10 May 2022 06:19:45 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210002-nct05018650</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210002-nct05018650</guid><description><![CDATA[<p>approval_date: Wed, 04 May 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05018650title:</p><p>ide_number: G210002</p><p>nct_number: NCT05018650</p><p>sponsor_name: Route 92 Medical, Inc.</p><p>study_title: A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients (SUMMIT MAX)</p>]]></description></item><item><title>G200227-NCT04589507</title><pubDate>Tue, 03 May 2022 06:17:36 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200227-nct04589507</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200227-nct04589507</guid><description><![CDATA[<p>approval_date: Thu, 28 Apr 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04589507title:</p><p>ide_number: G200227</p><p>nct_number: NCT04589507</p><p>sponsor_name: Micron Medical Corporation</p><p>study_title: Prospective, Multi-center, Randomized Trial of the Protect PNS for Refractory Overactive Bladder (OAB) – “GUARDIAN” Study</p>]]></description></item><item><title>G210374-NCT05234749</title><pubDate>Tue, 19 Apr 2022 06:08:48 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210374-nct05234749</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210374-nct05234749</guid><description><![CDATA[<p>approval_date: Thu, 07 Apr 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05234749title:</p><p>ide_number: G210374</p><p>nct_number: NCT05234749</p><p>sponsor_name: CyndRx</p><p>study_title: The SEAL TO HEAL Study: Study to EvALuate Time TO HEmostasis of AbsorbaSeaL</p>]]></description></item><item><title>G210238-NCT05096572</title><pubDate>Tue, 19 Apr 2022 06:07:26 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210238-nct05096572</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210238-nct05096572</guid><description><![CDATA[<p>approval_date: Thu, 07 Apr 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05096572title:</p><p>ide_number: G210238</p><p>nct_number: NCT05096572</p><p>sponsor_name: St. Joseph's Hospital and Medical Center, Phoenix</p><p>study_title: A Randomized Cross-Over Trial of Deep Brain Stimulation (DBS) of the Posterior Subthalamic Area (PSA), Ventral Intermediate Nucleus of the Thalamus (VIM), and VIM+PSA on Essential Tremor (ET)</p>]]></description></item><item><title>G200126-3-NCT04477603</title><pubDate>Tue, 29 Mar 2022 06:05:32 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200126-3-nct04477603</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200126-3-nct04477603</guid><description><![CDATA[<p>approval_date: Wed, 23 Mar 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04477603title:</p><p>ide_number: G200126</p><p>nct_number: NCT04477603</p><p>sponsor_name: Abiomed Inc.</p><p>study_title: Use of the Impella ECP in Patients Undergoing an Elective High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study</p>]]></description></item><item><title>G050016-NCT01984151</title><pubDate>Tue, 29 Mar 2022 06:04:14 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g050016-nct01984151</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g050016-nct01984151</guid><description><![CDATA[<p>approval_date: Wed, 23 Mar 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT01984151title:</p><p>ide_number: G050016</p><p>nct_number: NCT01984151</p><p>sponsor_name: VUMC</p><p>study_title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating Bilateral-Subthalamic Nucleus Deep Brain Stimulation in Subjects with Early Stage Parkinson’s Disease</p>]]></description></item><item><title>G210227-NCT05163548</title><pubDate>Tue, 29 Mar 2022 06:03:02 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210227-nct05163548</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210227-nct05163548</guid><description><![CDATA[<p>approval_date: Thu, 17 Mar 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05163548title:</p><p>ide_number: G210227</p><p>nct_number: NCT05163548</p><p>sponsor_name: Vivasure</p><p>study_title: Early Feasibility Study of the Vivasure PerQseal®+ (PerQseal® Plus) Vascular Closure Device when used to Achieve Hemostasis of Common Femoral Arteriotomies Created by 14 to 22 F Sheaths in Patients Undergoing Percutaneous Transcatheter Procedures</p>]]></description></item><item><title>G190208-NCT04197336</title><pubDate>Tue, 22 Mar 2022 05:59:51 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190208-nct04197336</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190208-nct04197336</guid><description><![CDATA[<p>approval_date: Thu, 17 Mar 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04197336title:</p><p>ide_number: G190208</p><p>nct_number: NCT04197336</p><p>sponsor_name: Johns Hopkins University</p><p>study_title: Bariatric Embolization of Arteries With Imaging Visible Embolics</p>]]></description></item><item><title>G210258-NCT05174312</title><pubDate>Tue, 22 Mar 2022 05:58:37 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210258-nct05174312</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210258-nct05174312</guid><description><![CDATA[<p>approval_date: Thu, 17 Mar 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05174312title:</p><p>ide_number: G210258</p><p>nct_number: NCT05174312</p><p>sponsor_name: Reprieve Cardiovascular, Inc</p><p>study_title: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) - FASTR Trial</p>]]></description></item><item><title>G200362-NCT04975880</title><pubDate>Tue, 22 Mar 2022 05:57:15 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200362-nct04975880</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200362-nct04975880</guid><description><![CDATA[<p>approval_date: Thu, 17 Mar 2022 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04975880title:</p><p>ide_number: G200362</p><p>nct_number: NCT04975880</p><p>sponsor_name: Quanta Dialysis Technologies Ltd</p><p>study_title: A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis</p>]]></description></item><item><title>G200212-NCT05152524</title><pubDate>Tue, 08 Mar 2022 06:24:24 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200212-nct05152524</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200212-nct05152524</guid><description><![CDATA[<p>approval_date: Thu, 03 Mar 2022 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05152524?term=NCT05152524&draw=2&rank=1title:</p><p>ide_number: G200212</p><p>nct_number: NCT05152524</p><p>sponsor_name: Rapid Medical</p><p>study_title: Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever</p>]]></description></item><item><title>G210218-NCT05174767</title><pubDate>Tue, 08 Mar 2022 06:22:54 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210218-nct05174767</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210218-nct05174767</guid><description><![CDATA[<p>approval_date: Thu, 03 Mar 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05174767?term=NCT05174767&draw=2&rank=1title:</p><p>ide_number: G210218</p><p>nct_number: NCT05174767</p><p>sponsor_name: CryoLife, Inc.</p><p>study_title: A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE</p>]]></description></item><item><title>G210288-NCT05142566</title><pubDate>Tue, 15 Feb 2022 06:15:31 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210288-nct05142566</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210288-nct05142566</guid><description><![CDATA[<p>approval_date: Thu, 10 Feb 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05142566title:</p><p>ide_number: G210288</p><p>nct_number: NCT05142566</p><p>sponsor_name: Essential Medical, Inc.</p><p>study_title: Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study</p>]]></description></item><item><title>G200248-NCT04989504</title><pubDate>Tue, 15 Feb 2022 06:14:11 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200248-nct04989504</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200248-nct04989504</guid><description><![CDATA[<p>approval_date: Thu, 10 Feb 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04989504title:</p><p>ide_number: G200248</p><p>nct_number: NCT04989504</p><p>sponsor_name: Alliance for Clinical Trials in Oncology</p><p>study_title: Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial</p>]]></description></item><item><title>G200042-NCT05064709</title><pubDate>Tue, 01 Feb 2022 13:30:34 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200042-nct05064709</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200042-nct05064709</guid><description><![CDATA[<p>approval_date: Thu, 27 Jan 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05064709?term=NCT05064709&draw=2&rank=1title:</p><p>ide_number: G200042</p><p>nct_number: NCT05064709</p><p>sponsor_name: Impulse Dynamics</p><p>study_title: Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction</p>]]></description></item><item><title>G210281-NCT05136820</title><pubDate>Tue, 01 Feb 2022 13:29:13 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210281-nct05136820</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210281-nct05136820</guid><description><![CDATA[<p>approval_date: Thu, 27 Jan 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05136820?term=NCT05136820&draw=2&rank=1title:</p><p>ide_number: G210281</p><p>nct_number: NCT05136820</p><p>sponsor_name: Occlutech International AB</p><p>study_title: Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study</p>]]></description></item><item><title>G210284-NCT05061004</title><pubDate>Tue, 18 Jan 2022 08:01:15 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210284-nct05061004</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210284-nct05061004</guid><description><![CDATA[<p>approval_date: Thu, 13 Jan 2022 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05061004title:</p><p>ide_number: G210284</p><p>nct_number: NCT05061004</p><p>sponsor_name: Abbott</p><p>study_title: Cephea Mitral Valve System</p>]]></description></item><item><title>G210170-NCT05120193</title><pubDate>Tue, 18 Jan 2022 07:57:38 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210170-nct05120193</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210170-nct05120193</guid><description><![CDATA[<p>approval_date: Thu, 13 Jan 2022 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT05120193title:</p><p>ide_number: G210170</p><p>nct_number: NCT05120193</p><p>sponsor_name: Affera, Inc.</p><p>study_title: Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System</p>]]></description></item><item><title>G210195–NCT04985773</title><pubDate>Mon, 10 Jan 2022 11:24:33 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210195-nct04985773</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210195-nct04985773</guid><description><![CDATA[<p>approval_date: Thu, 30 Dec 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04985773title:</p><p>ide_number: G210195</p><p>nct_number: NCT04985773</p><p>sponsor_name: Infraredx</p><p>study_title: A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)</p>]]></description></item><item><title>G200251-NCT05127915</title><pubDate>Mon, 10 Jan 2022 11:23:12 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200251-nct05127915</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200251-nct05127915</guid><description><![CDATA[<p>approval_date: Thu, 30 Dec 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05127915title:</p><p>ide_number: G200251</p><p>nct_number: NCT05127915</p><p>sponsor_name: Adient Medical</p><p>study_title: A Prospective, Multicenter, Pivotal Study With Randomized Controlled Prophylactic and Independent Therapeutic Cohorts to Evaluate the Safety and Efficacy of an Absorbable Vena Cava Filter for Pulmonary Embolism Prevention</p>]]></description></item><item><title>G210030-NCT04865588</title><pubDate>Tue, 14 Dec 2021 06:54:08 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210030-nct04865588</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210030-nct04865588</guid><description><![CDATA[<p>approval_date: Thu, 09 Dec 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04865588?term=NCT04865588&draw=2&rank=1title:</p><p>ide_number: G210030</p><p>nct_number: NCT04865588</p><p>sponsor_name: Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.</p><p>study_title: Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions</p>]]></description></item><item><title>G210145-NCT05082987</title><pubDate>Tue, 14 Dec 2021 06:49:22 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210145-nct05082987</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210145-nct05082987</guid><description><![CDATA[<p>approval_date: Thu, 09 Dec 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05082987?term=NCT05082987&draw=2&rank=1title:</p><p>ide_number: G210145</p><p>nct_number: NCT05082987</p><p>sponsor_name: Tornier, Inc</p><p>study_title: PERFORM Stemless Reverse</p>]]></description></item><item><title>G210230-NCT05046730 </title><pubDate>Tue, 14 Dec 2021 06:44:53 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210230-nct05046730</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210230-nct05046730</guid><description><![CDATA[<p>approval_date: Thu, 09 Dec 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05046730title:</p><p>ide_number: G210230</p><p>nct_number: NCT05046730 </p><p>sponsor_name: GI Windows, Inc.</p><p>study_title: SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression: A Study to Evaluate Safety and Effectiveness of Self-Forming Magnet (SFM) Anastomosis Device: A Historically Controlled Propensity Matched Study </p>]]></description></item><item><title>G200131-NCT05107206</title><pubDate>Tue, 14 Dec 2021 06:42:47 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200131-nct05107206</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200131-nct05107206</guid><description><![CDATA[<p>approval_date: Thu, 09 Dec 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05107206?term=NCT05107206&draw=2&rank=1title:</p><p>ide_number: G200131</p><p>nct_number: NCT05107206</p><p>sponsor_name: NeuroVasc Technologies, Inc.</p><p>study_title: Envi-SR</p>]]></description></item><item><title>G210056-NCT05045794</title><pubDate>Tue, 14 Dec 2021 06:41:39 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210056-nct05045794</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210056-nct05045794</guid><description><![CDATA[<p>approval_date: Thu, 09 Dec 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05045794title:</p><p>ide_number: G210056</p><p>nct_number: NCT05045794</p><p>sponsor_name: Bridge to Life Ltd.</p><p>study_title: A Multicenter, Prospective, Open-label, Randomized Controlled Clinical Trial to Compare the Safety and Effectiveness of the VitaSmart Liver Machine Perfusion System With Static Cold Storage for Organ Preservation Prior to Liver Transplantation</p>]]></description></item><item><title>G200030-NCT04124341</title><pubDate>Tue, 14 Dec 2021 06:40:33 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200030-nct04124341</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200030-nct04124341</guid><description><![CDATA[<p>approval_date: Thu, 09 Dec 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04124341title:</p><p>ide_number: G200030</p><p>nct_number: NCT04124341</p><p>sponsor_name: University of Minnesota</p><p>study_title: Epidural Prefrontal Cortical Stimulation (EpCS) in Severe Treatment Resistant Depression</p>]]></description></item><item><title>G130018-NCT04728087</title><pubDate>Tue, 23 Nov 2021 07:30:52 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g130018-nct04728087</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g130018-nct04728087</guid><description><![CDATA[<p>approval_date: Thu, 18 Nov 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04728087title:</p><p>ide_number: G130018</p><p>nct_number: NCT04728087</p><p>sponsor_name: Hemostasis, LLC</p><p>study_title: ACCEL® Absorbable Hemostat Powder Clinical Trial</p>]]></description></item><item><title>G210263-NCT05093504</title><pubDate>Tue, 23 Nov 2021 07:28:49 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210263-nct05093504</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210263-nct05093504</guid><description><![CDATA[<p>approval_date: Thu, 18 Nov 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05093504title:</p><p>ide_number: G210263</p><p>nct_number: NCT05093504</p><p>sponsor_name: CytoSorbents, Inc</p><p>study_title: Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban &#x26; Rivaroxaban (STAR-D): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery</p>]]></description></item><item><title>G190148-NCT04849169</title><pubDate>Tue, 23 Nov 2021 07:26:18 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190148-nct04849169</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190148-nct04849169</guid><description><![CDATA[<p>approval_date: Thu, 18 Nov 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04849169title:</p><p>ide_number: G190148</p><p>nct_number: NCT04849169</p><p>sponsor_name: Vascular Solutions LLC</p><p>study_title: A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter Performed Under an Exception From Informed Consent (EFIC) (Ringer IDE Study)</p>]]></description></item><item><title>G210274-NCT05103527</title><pubDate>Tue, 23 Nov 2021 07:03:38 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210274-nct05103527</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210274-nct05103527</guid><description><![CDATA[<p>approval_date: Thu, 18 Nov 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05103527title:</p><p>ide_number: G210274</p><p>nct_number: NCT05103527</p><p>sponsor_name: Kenneth B Chapman</p><p>study_title: Dorsal Root Ganglion Stimulation Outcomes for the Treatment of Mechanical Knee Pain Among Patients With Osteoarthritis of the Surgical and Non-surgical Knee</p>]]></description></item><item><title>G210080-NCT04886505</title><pubDate>Tue, 23 Nov 2021 06:55:06 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210080-nct04886505</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210080-nct04886505</guid><description><![CDATA[<p>approval_date: Thu, 18 Nov 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04886505title:</p><p>ide_number: G210080</p><p>nct_number: NCT04886505</p><p>sponsor_name: Evasc Medical Systems Corp.</p><p>study_title: An Early Feasibility Study Assessing the Safety, Technical Performance, and Efficacy of the Electrolytic eCLIPs Bifurcation System for the Treatment of Intracranial Bifurcation Aneurysms</p>]]></description></item><item><title>G200093-1-NCT04465201</title><pubDate>Tue, 23 Nov 2021 06:54:04 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200093-1-nct04465201</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200093-1-nct04465201</guid><description><![CDATA[<p>approval_date: Thu, 18 Nov 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04465201title:</p><p>ide_number: G200093</p><p>nct_number: NCT04465201</p><p>sponsor_name: Abiomed Inc.</p><p>study_title: Advanced Impella® SmartAssist® System for Patient Monitoring &#x26; Treatment: An Early Feasibility Study</p>]]></description></item><item><title>G210003-NCT04814134</title><pubDate>Tue, 23 Nov 2021 06:53:03 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210003-nct04814134</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210003-nct04814134</guid><description><![CDATA[<p>approval_date: Thu, 18 Nov 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04814134title:</p><p>ide_number: G210003</p><p>nct_number: NCT04814134</p><p>sponsor_name: Cardionomic Inc.</p><p>study_title: The Cardiac Pulmonary Nerve Stimulation (CPNS) Pilot Study</p>]]></description></item><item><title>G160196-NCT05102019</title><pubDate>Tue, 23 Nov 2021 06:52:00 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160196-nct05102019</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160196-nct05102019</guid><description><![CDATA[<p>approval_date: Thu, 18 Nov 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT05102019title:</p><p>ide_number: G160196</p><p>nct_number: NCT05102019</p><p>sponsor_name: Neovasc Inc.</p><p>study_title: Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II</p>]]></description></item><item><title>G210167-NCT05069558</title><pubDate>Tue, 09 Nov 2021 06:03:42 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210167-nct05069558</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210167-nct05069558</guid><description><![CDATA[<p>approval_date: Thu, 04 Nov 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT05069558title:</p><p>ide_number: G210167</p><p>nct_number: NCT05069558</p><p>sponsor_name: Occlutech International AB</p><p>study_title: Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion</p>]]></description></item><item><title>G210063-NCT04835428</title><pubDate>Tue, 09 Nov 2021 06:02:29 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210063-nct04835428</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210063-nct04835428</guid><description><![CDATA[<p>approval_date: Thu, 04 Nov 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04835428title:</p><p>ide_number: G210063</p><p>nct_number: NCT04835428</p><p>sponsor_name: AgNovos Healthcare, LLC</p><p>study_title: A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment</p>]]></description></item><item><title>G200118-NCT04086550  </title><pubDate>Tue, 02 Nov 2021 06:46:36 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200118-nct04086550</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200118-nct04086550</guid><description><![CDATA[<p>approval_date: Thu, 28 Oct 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04086550title:</p><p>ide_number: G200118</p><p>nct_number: NCT04086550</p><p>sponsor_name: Polyganics BV</p><p>study_title: Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery</p>]]></description></item><item><title>G210045-NCT04897776</title><pubDate>Tue, 02 Nov 2021 06:44:37 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210045-nct04897776-0</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210045-nct04897776-0</guid><description><![CDATA[<p>approval_date: Mon, 25 Oct 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04897776title:</p><p>ide_number: G210045</p><p>nct_number: NCT04897776</p><p>sponsor_name: Yale University</p><p>study_title: Thalamic Stimulation to Prevent Impaired Consciousness in Epilepsy</p>]]></description></item><item><title>G210023-NCT04876040</title><pubDate>Tue, 02 Nov 2021 06:41:59 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210023-nct04876040</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210023-nct04876040</guid><description><![CDATA[<p>approval_date: Mon, 25 Oct 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04876040title:</p><p>ide_number: G210023</p><p>nct_number: NCT04876040</p><p>sponsor_name: TherOx</p><p>study_title: A Multi-Center Randomized-Controlled Trial To Evaluate The Safety And Feasibility of The Delivery Of Intracoronary Hyperoxemic Supersaturated Oxygen Therapy For 60 Minutes In Patients With St Elevation Myocardial Infarction (STEMI) And Cardiogenic Shock After Successful Reperfusion (Via PCI) ≤ Six Hours  After Symptom Onset Compared To Standard Therapy</p>]]></description></item><item><title>G170218-1-NCT04658017</title><pubDate>Tue, 02 Nov 2021 06:39:21 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g170218-1-nct04658017</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g170218-1-nct04658017</guid><description><![CDATA[<p>approval_date: Mon, 25 Oct 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04658017title:</p><p>ide_number: G170218</p><p>nct_number: NCT04658017</p><p>sponsor_name: Boa Biomedical, Inc.</p><p>study_title: Feasibility of Hemodialysis With the GARNET Device in Chronic Hemodialysis Patients With a Bloodstream Infection</p>]]></description></item><item><title>G210045-NCT04897776</title><pubDate>Tue, 02 Nov 2021 06:37:53 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210045-nct04897776</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210045-nct04897776</guid><description><![CDATA[<p>approval_date: Mon, 25 Oct 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04897776title:</p><p>ide_number: G210045</p><p>nct_number: NCT04897776</p><p>sponsor_name: Yale University</p><p>study_title: Early Feasibility Study of Thalamic Stimulation to Prevent Impaired Consciousness in Epilepsy</p>]]></description></item><item><title>G100102-NCT03463954</title><pubDate>Tue, 02 Nov 2021 06:35:28 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g100102-nct03463954</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g100102-nct03463954</guid><description><![CDATA[<p>approval_date: Fri, 22 Oct 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03463954title:</p><p>ide_number: G100102</p><p>nct_number: NCT03463954</p><p>sponsor_name: Novian Health Inc.</p><p>study_title: Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003)</p>]]></description></item><item><title>G160173-NCT04982835</title><pubDate>Tue, 02 Nov 2021 06:34:03 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160173-nct04982835</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160173-nct04982835</guid><description><![CDATA[<p>approval_date: Sat, 23 Oct 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04982835title:</p><p>ide_number: G160173</p><p>nct_number: NCT04982835</p><p>sponsor_name: Spinal Kinetics</p><p>study_title: M6®-C Artificial Cervical Disc Two-Level IDE Pivotal Study</p>]]></description></item><item><title>G210150-NCT04863664</title><pubDate>Tue, 02 Nov 2021 06:32:39 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210150-nct04863664</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210150-nct04863664</guid><description><![CDATA[<p>approval_date: Fri, 15 Oct 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04863664title:</p><p>ide_number: G210150</p><p>nct_number: NCT04863664</p><p>sponsor_name: Medtronic Cardiac Rhythm and Heart Failure</p><p>study_title: Lead EvaluAtion for Defibrillation and Reliability (LEADR)</p>]]></description></item><item><title>G180190-NCT04521569</title><pubDate>Wed, 13 Oct 2021 13:31:43 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180190-nct04521569</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180190-nct04521569</guid><description><![CDATA[<p>approval_date: Thu, 07 Oct 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04521569title:</p><p>ide_number: G180190</p><p>nct_number: NCT04521569</p><p>sponsor_name: University of Maryland, Baltimore</p><p>study_title: A Randomized, Blinded, Multi-site, Pilot Study to Evaluate Adenosine 2A Receptor Agonist (REGADENOSON) in the Rehabilitation of Marginal Donor Lungs</p>]]></description></item><item><title>G210154-NCT04972097</title><pubDate>Wed, 13 Oct 2021 13:28:32 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210154-nct04972097</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210154-nct04972097</guid><description><![CDATA[<p>approval_date: Thu, 07 Oct 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04972097title:</p><p>ide_number: G210154</p><p>nct_number: NCT04972097</p><p>sponsor_name: Angiodynamics, Inc.</p><p>study_title: Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population</p>]]></description></item><item><title>G190110-NCT05010850</title><pubDate>Tue, 05 Oct 2021 06:03:57 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190110-nct05010850</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190110-nct05010850</guid><description><![CDATA[<p>approval_date: Thu, 30 Sep 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05010850title:</p><p>ide_number: G190110</p><p>nct_number: NCT05010850</p><p>sponsor_name: SafeHeal Inc.</p><p>study_title: SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study</p>]]></description></item><item><title>G210173-NCT05003843</title><pubDate>Tue, 05 Oct 2021 06:03:06 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210173-nct05003843</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210173-nct05003843</guid><description><![CDATA[<p>approval_date: Thu, 30 Sep 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT05003843title:</p><p>ide_number: G210173</p><p>nct_number: NCT05003843</p><p>sponsor_name: Penumbra Inc.</p><p>study_title: BOLT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System</p>]]></description></item><item><title>G210076-NCT04939740</title><pubDate>Mon, 27 Sep 2021 06:32:16 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210076-nct04939740</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210076-nct04939740</guid><description><![CDATA[<p>approval_date: Thu, 23 Sep 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04939740title:</p><p>ide_number: G210076</p><p>nct_number: NCT04939740</p><p>sponsor_name: AngioSafe, Inc</p><p>study_title: Early Feasibility Study of AngioSafe Coronary CTO Crossing System (RESTOR-COR-1)</p>]]></description></item><item><title>G190313-NCT04276090</title><pubDate>Mon, 27 Sep 2021 06:31:19 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190313-nct04276090</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190313-nct04276090</guid><description><![CDATA[<p>approval_date: Fri, 17 Sep 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04276090title:</p><p>ide_number: G190313</p><p>nct_number: NCT04276090</p><p>sponsor_name: Michael J Cavnar, MD</p><p>study_title: Feasibility Pilot of Hepatic Arterial Infusion Chemotherapy in a Rural Catchment Area, Using the Codman Vascular Catheter With the Synchromed II Pump, for Patients With Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangiocarcinoma</p>]]></description></item><item><title>G210009-NCT04879940</title><pubDate>Mon, 27 Sep 2021 06:30:17 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210009-nct04879940</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210009-nct04879940</guid><description><![CDATA[<p>approval_date: Fri, 17 Sep 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04879940title:</p><p>ide_number: G210009</p><p>nct_number: NCT04879940</p><p>sponsor_name: H. Lee Moffitt Cancer Center and Research Institute</p><p>study_title: Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization in Patients With Localized Prostate Carcinoma and Obstructive Lower Urinary Tract Symptoms</p>]]></description></item><item><title>G200338-NCT04891289</title><pubDate>Tue, 07 Sep 2021 06:38:19 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200338-nct04891289</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200338-nct04891289</guid><description><![CDATA[<p>approval_date: Thu, 02 Sep 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04891289title:</p><p>ide_number: G200338</p><p>nct_number: NCT04891289</p><p>sponsor_name: Memorial Sloan Kettering Cancer Center</p><p>study_title: A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma</p>]]></description></item><item><title>G200322-NCT04801771</title><pubDate>Tue, 07 Sep 2021 06:37:11 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200322-nct04801771</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200322-nct04801771</guid><description><![CDATA[<p>approval_date: Thu, 02 Sep 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04801771title:</p><p>ide_number: G200322</p><p>nct_number: NCT04801771</p><p>sponsor_name: Inspire Medical Systems, Inc.</p><p>study_title: Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea</p>]]></description></item><item><title>G210069-NCT04943172</title><pubDate>Tue, 07 Sep 2021 06:36:11 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210069-nct04943172</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210069-nct04943172</guid><description><![CDATA[<p>approval_date: Tue, 31 Aug 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04943172title:</p><p>ide_number: G210069</p><p>nct_number: NCT04943172</p><p>sponsor_name: Hancock Jaffe Laboratiores, Inc</p><p>study_title: The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study</p>]]></description></item><item><title>G200170-NCT04662320</title><pubDate>Tue, 07 Sep 2021 06:35:06 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200170-nct04662320</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200170-nct04662320</guid><description><![CDATA[<p>approval_date: Mon, 30 Aug 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04662320title:</p><p>ide_number: G200170</p><p>nct_number: NCT04662320</p><p>sponsor_name: Checkpoint Surgical Inc.</p><p>study_title: Promoting Healing Of Nerves Through Electrical Stimulation</p>]]></description></item><item><title>G210111-NCT04702451</title><pubDate>Tue, 07 Sep 2021 06:33:56 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210111-nct04702451</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210111-nct04702451</guid><description><![CDATA[<p>approval_date: Thu, 26 Aug 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04702451title:</p><p>ide_number: G210111</p><p>nct_number: NCT04702451</p><p>sponsor_name: Volta Medical</p><p>study_title: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation</p>]]></description></item><item><title>G210081-NCT04976530</title><pubDate>Tue, 07 Sep 2021 06:32:54 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210081-nct04976530</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210081-nct04976530</guid><description><![CDATA[<p>approval_date: Thu, 26 Aug 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04976530title:</p><p>ide_number: G210081</p><p>nct_number: NCT04976530</p><p>sponsor_name: CytoSorbents, Inc</p><p>study_title: Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor With the Intraoperative Use of the DrugSorb-ATR Device in Patients Undergoing On-pump Cardiothoracic Surgery Within 48hrs From Last Ticagrelor Dose</p>]]></description></item><item><title>G200347-NCT04881162</title><pubDate>Tue, 07 Sep 2021 06:31:50 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200347-nct04881162</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200347-nct04881162</guid><description><![CDATA[<p>approval_date: Thu, 26 Aug 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04881162title:</p><p>ide_number: G200347</p><p>nct_number: NCT04881162</p><p>sponsor_name: Silk Road Medical</p><p>study_title: Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy</p>]]></description></item><item><title>G150198-NCT02725463</title><pubDate>Tue, 17 Aug 2021 06:37:08 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150198-nct02725463</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150198-nct02725463</guid><description><![CDATA[<p>approval_date: Fri, 06 Aug 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT02725463title:</p><p>ide_number: G150198</p><p>nct_number: NCT02725463</p><p>sponsor_name: Johns Hopkins University</p><p>study_title: First-in-Human Early Feasibility Study of Safety, Tolerability and Efficacy for a Multichannel Vestibular Implant in Individuals With Bilateral Severe-to-Profound Loss of Vestibular Sensation</p>]]></description></item><item><title>G200024-NCT04339452</title><pubDate>Tue, 17 Aug 2021 06:36:10 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200024-nct04339452</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200024-nct04339452</guid><description><![CDATA[<p>approval_date: Fri, 06 Aug 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04339452title:</p><p>ide_number: G200024</p><p>nct_number: NCT04339452</p><p>sponsor_name: Medical College of Wisconsin</p><p>study_title: mpella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: A Single Center Prospective Observational Study</p>]]></description></item><item><title>G200177-NCT04904354</title><pubDate>Tue, 17 Aug 2021 06:35:12 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200177-nct04904354</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200177-nct04904354</guid><description><![CDATA[<p>approval_date: Fri, 06 Aug 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04904354title:</p><p>ide_number: G200177</p><p>nct_number: NCT04904354</p><p>sponsor_name: Acutus Medical</p><p>study_title: AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF)</p>]]></description></item><item><title>G120115-NCT01812174</title><pubDate>Tue, 03 Aug 2021 06:42:05 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g120115-nct01812174</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g120115-nct01812174</guid><description><![CDATA[<p>approval_date: Thu, 29 Jul 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT01812174title:</p><p>ide_number: G120115</p><p>nct_number: NCT01812174</p><p>sponsor_name: On-X Life Technologies, Inc.</p><p>study_title: On-X Heart Valve - 17mm Aortic and 23mm Mitral</p>]]></description></item><item><title>G200119-2-NCT04433065</title><pubDate>Tue, 03 Aug 2021 06:41:00 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200119-2-nct04433065</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200119-2-nct04433065</guid><description><![CDATA[<p>approval_date: Thu, 29 Jul 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04433065title:</p><p>ide_number: G200119</p><p>nct_number: NCT04433065</p><p>sponsor_name: Medtronic Cardiovascular</p><p>study_title: The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System</p>]]></description></item><item><title>G200310-NCT04816591</title><pubDate>Thu, 29 Jul 2021 05:49:54 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200310-nct04816591</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200310-nct04816591</guid><description><![CDATA[<p>approval_date: Thu, 17 Jun 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04816591title:</p><p>ide_number: G200310</p><p>nct_number: NCT04816591</p><p>sponsor_name: Cerenovus, Part of DePuy Synthes Products, Inc.</p><p>study_title: Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA</p>]]></description></item><item><title>G210071-NCT04892472</title><pubDate>Fri, 23 Jul 2021 11:09:43 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210071-nct04892472</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210071-nct04892472</guid><description><![CDATA[<p>approval_date: Thu, 22 Jul 2021 00:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04892472title:</p><p>ide_number: G210071</p><p>nct_number: NCT04892472</p><p>sponsor_name: NovoCure GmbH</p><p>study_title: EF-36/Keynote B36: A Pilot, Single Arm, Open-Label Study of Tumor Treating Fields(TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Intrathoracic Non-small Cell Lung Cancer</p>]]></description></item><item><title>G210088-NCT04905290</title><pubDate>Fri, 23 Jul 2021 11:01:39 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210088-nct04905290</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210088-nct04905290</guid><description><![CDATA[<p>approval_date: Thu, 22 Jul 2021 00:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04905290title:</p><p>ide_number: G210088</p><p>nct_number: NCT04905290</p><p>sponsor_name: Medtronic</p><p>study_title: Conduction System Pacing Optimized Therapy Study</p>]]></description></item><item><title>G210017-NCT04883411</title><pubDate>Tue, 13 Jul 2021 05:54:09 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210017-nct04883411</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210017-nct04883411</guid><description><![CDATA[<p>approval_date: Thu, 08 Jul 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04883411title:</p><p>ide_number: G210017</p><p>nct_number: NCT04883411</p><p>sponsor_name: ReVivo Medical, Corp.</p><p>study_title: First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate</p>]]></description></item><item><title>G200272-NCT04890821</title><pubDate>Tue, 06 Jul 2021 06:41:16 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200272-nct04890821</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200272-nct04890821</guid><description><![CDATA[<p>approval_date: Thu, 01 Jul 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04890821title:</p><p>ide_number: G200272</p><p>nct_number: NCT04890821</p><p>sponsor_name: Cardiac Implants LLC</p><p>study_title: Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation</p>]]></description></item><item><title>G190185-NCT04900844</title><pubDate>Tue, 06 Jul 2021 06:36:14 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190185-nct04900844</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190185-nct04900844</guid><description><![CDATA[<p>approval_date: Thu, 01 Jul 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04900844title:</p><p>ide_number: G190185</p><p>nct_number: NCT04900844</p><p>sponsor_name: InspireMD</p><p>study_title: A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard™ Carotid Stent System When Used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting</p>]]></description></item><item><title>G210043-NCT04818541  </title><pubDate>Tue, 08 Jun 2021 06:45:18 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210043-nct04818541</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210043-nct04818541</guid><description><![CDATA[<p>approval_date: Thu, 03 Jun 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04818541title:</p><p>ide_number: G210043</p><p>nct_number: NCT04818541</p><p>sponsor_name: Vivasure Medical Limited</p><p>study_title: Early Feasibility Study of the Vivasure PerQseal® Closure Device System After Use of the Impella Device for Cardiogenic Shock or Protected Percutaneous Coronary Intervention</p>]]></description></item><item><title>G140243-NCT04862156</title><pubDate>Tue, 08 Jun 2021 06:44:06 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g140243-nct04862156</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g140243-nct04862156</guid><description><![CDATA[<p>approval_date: Thu, 03 Jun 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04862156title:</p><p>ide_number: G140243</p><p>nct_number: NCT04862156</p><p>sponsor_name: OrganOx Ltd</p><p>study_title: Continued Access Protocol Study for the use of the OrganOx metra normothermic machine perfusion device in human liver transplantation</p>]]></description></item><item><title>G200044-NCT04400643  </title><pubDate>Tue, 08 Jun 2021 06:42:30 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200044-nct04400643</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200044-nct04400643</guid><description><![CDATA[<p>approval_date: Wed, 26 May 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04400643title:</p><p>ide_number: G200044</p><p>nct_number: NCT04400643</p><p>sponsor_name: Hamilton Medical AG</p><p>study_title: INTELLiVENT-ASV Software</p>]]></description></item><item><title>G200134-NCT04685317  </title><pubDate>Tue, 08 Jun 2021 06:40:09 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200134-nct04685317</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200134-nct04685317</guid><description><![CDATA[<p>approval_date: Thu, 20 May 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT04685317title:</p><p>ide_number: G200134</p><p>nct_number: NCT04685317</p><p>sponsor_name: Malini Madhavan</p><p>study_title: A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation</p>]]></description></item><item><title>G200245-NCT04877847  </title><pubDate>Tue, 08 Jun 2021 06:38:32 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200245-nct04877847</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200245-nct04877847</guid><description><![CDATA[<p>approval_date: Wed, 26 May 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04877847title:</p><p>ide_number: G200245</p><p>nct_number: NCT04877847</p><p>sponsor_name: Sonogenix</p><p>study_title: Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial</p>]]></description></item><item><title>G210078-NCT04852783  </title><pubDate>Tue, 08 Jun 2021 06:37:03 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210078-nct04852783</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g210078-nct04852783</guid><description><![CDATA[<p>approval_date: Wed, 26 May 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04852783title:</p><p>ide_number: G210078</p><p>nct_number: NCT04852783</p><p>sponsor_name: Cerus Endovascular, Ltd</p><p>study_title: US IDE Study of the Contour NEurovasCular System™ for IntraCranial A neurysm Repair (NECC Trial) </p>]]></description></item><item><title>G190128-1-NCT03997305  </title><pubDate>Tue, 08 Jun 2021 06:35:33 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190128-1-nct03997305</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190128-1-nct03997305</guid><description><![CDATA[<p>approval_date: Wed, 26 May 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03997305title:</p><p>ide_number: G190128</p><p>nct_number: NCT03997305</p><p>sponsor_name: 4C Medical Technologies, Inc.</p><p>study_title: AltaValve Early Feasibility Study Protocol</p>]]></description></item><item><title>G200267-NCT04741009  </title><pubDate>Tue, 25 May 2021 06:25:03 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200267-nct04741009</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200267-nct04741009</guid><description><![CDATA[<p>approval_date: Thu, 20 May 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04741009title:</p><p>ide_number: G200267</p><p>nct_number: NCT04741009</p><p>sponsor_name: Cochlear</p><p>study_title: A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Feasibility Investigation of Hearing Performance Using the CI632 in Adults With Low-frequency Residual Hearing</p>]]></description></item><item><title>G200233-NCT04796792  </title><pubDate>Tue, 25 May 2021 06:22:26 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200233-nct04796792</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200233-nct04796792</guid><description><![CDATA[<p>approval_date: Thu, 20 May 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04796792title:</p><p>ide_number: G200233</p><p>nct_number: NCT04796792</p><p>sponsor_name: University of Washington</p><p>study_title: Ultrasound Technology to Fragment and Reposition Urinary Stones</p>]]></description></item><item><title>G200352-NCT04736121</title><pubDate>Tue, 11 May 2021 06:20:03 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200352-nct04736121</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200352-nct04736121</guid><description><![CDATA[<p>approval_date: Wed, 05 May 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04736121title:</p><p>ide_number: G200352</p><p>nct_number: NCT04736121</p><p>sponsor_name: Sirtex Medical</p><p>study_title: A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety &#x26; Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR &#x26; ORR in Unresectable Hepatocellular Carcinoma Patients</p>]]></description></item><item><title>G200318-NCT04799210</title><pubDate>Tue, 11 May 2021 06:17:36 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200318-nct04799210</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200318-nct04799210</guid><description><![CDATA[<p>approval_date: Tue, 04 May 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04799210title:</p><p>ide_number: G200318</p><p>nct_number: NCT04799210</p><p>sponsor_name: Eximis Surgical</p><p>study_title: Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System  ("Contain" Study)</p>]]></description></item><item><title>G200342-NCT04747626  </title><pubDate>Tue, 27 Apr 2021 06:48:30 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200342-nct04747626</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200342-nct04747626</guid><description><![CDATA[<p>approval_date: Fri, 16 Apr 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04747626title:</p><p>ide_number: G200342</p><p>nct_number: NCT04747626</p><p>sponsor_name: Eric Roselli, M. D.</p><p>study_title: B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair</p>]]></description></item><item><title>G200063-NCT04666480  </title><pubDate>Tue, 27 Apr 2021 06:46:48 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200063-nct04666480</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200063-nct04666480</guid><description><![CDATA[<p>approval_date: Fri, 16 Apr 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04666480title:</p><p>ide_number: G200063</p><p>nct_number: NCT04666480</p><p>sponsor_name: Polares Medical SA</p><p>study_title: Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Degenerative Mitral Regurgitation (EXPLORE DMR)</p>]]></description></item><item><title>G200063-NCT04666467  </title><pubDate>Tue, 27 Apr 2021 06:45:15 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200063-nct04666467</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200063-nct04666467</guid><description><![CDATA[<p>approval_date: Fri, 16 Apr 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04666467title:</p><p>ide_number: G200063</p><p>nct_number: NCT04666467</p><p>sponsor_name: Polares Medical SA</p><p>study_title: Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Functional Mitral Regurgitation (EXPLORE FMR)</p>]]></description></item><item><title>G200266-NCT04707885</title><pubDate>Tue, 27 Apr 2021 06:43:44 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200266-nct04707885</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200266-nct04707885</guid><description><![CDATA[<p>approval_date: Fri, 19 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04707885title:</p><p>ide_number: G200266</p><p>nct_number: NCT04707885</p><p>sponsor_name: Ohio State University</p><p>study_title: Clinical Utility of Residual Hearing in the Cochlear Implant Ear</p>]]></description></item><item><title>G200303-NCT04682652</title><pubDate>Tue, 27 Apr 2021 06:42:29 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200303-nct04682652</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200303-nct04682652</guid><description><![CDATA[<p>approval_date: Thu, 22 Apr 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT04682652title:</p><p>ide_number: G200303</p><p>nct_number: NCT04682652</p><p>sponsor_name: University of California, Los Angeles</p><p>study_title: GRAVITY: Genicular Artery Embolization Versus Observation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial</p>]]></description></item><item><title>G200015-NCT04392193  </title><pubDate>Tue, 27 Apr 2021 06:41:09 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200015-nct04392193</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200015-nct04392193</guid><description><![CDATA[<p>approval_date: Thu, 22 Apr 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04392193title:</p><p>ide_number: G200015</p><p>nct_number: NCT04392193</p><p>sponsor_name: Douglas L. Packer, MD</p><p>study_title: Proton Particle Therapy for Cardiac Arrhythmia Extracorporeal Energy Source Ablation of Cardiac Tissue: A First Stage Early Feasibility Study</p>]]></description></item><item><title>G200098-NCT04750642  </title><pubDate>Tue, 27 Apr 2021 06:39:33 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200098-nct04750642</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200098-nct04750642</guid><description><![CDATA[<p>approval_date: Thu, 22 Apr 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04750642title:</p><p>ide_number: G200098</p><p>nct_number: NCT04750642</p><p>sponsor_name: Cochlear</p><p>study_title: Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study</p>]]></description></item><item><title>G200280-NCT04714216  </title><pubDate>Tue, 27 Apr 2021 06:37:42 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200280-nct04714216</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200280-nct04714216</guid><description><![CDATA[<p>approval_date: Thu, 22 Apr 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04714216title:</p><p>ide_number: G200280</p><p>nct_number: NCT04714216</p><p>sponsor_name: Emory University</p><p>study_title: Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study</p>]]></description></item><item><title>G200288-NCT04746677</title><pubDate>Tue, 27 Apr 2021 06:34:42 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200288-nct04746677</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200288-nct04746677</guid><description><![CDATA[<p>approval_date: Fri, 16 Apr 2021 11:00:00 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NCT04524247</p><p>sponsor_name: University of Southern California</p><p>study_title: Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts</p>]]></description></item><item><title>G200271-NCT04663867  </title><pubDate>Tue, 20 Apr 2021 06:12:06 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200271-nct04663867</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200271-nct04663867</guid><description><![CDATA[<p>approval_date: Fri, 09 Apr 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04663867title:</p><p>ide_number: G200271</p><p>nct_number: NCT04663867</p><p>sponsor_name: AngioSafe, Inc.</p><p>study_title: Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System</p>]]></description></item><item><title>G200294-NCT04145635</title><pubDate>Mon, 12 Apr 2021 09:18:20 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200294-nct04145635</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200294-nct04145635</guid><description><![CDATA[<p>approval_date: Fri, 09 Apr 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04145635?term=NCT04145635&draw=2&rank=1title:</p><p>ide_number: G200294</p><p>nct_number: NCT04145635</p><p>sponsor_name: Procyrion</p><p>study_title: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome</p>]]></description></item><item><title>G190192-NCT04526938</title><pubDate>Mon, 12 Apr 2021 09:16:47 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190192-nct04526938</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190192-nct04526938</guid><description><![CDATA[<p>approval_date: Fri, 09 Apr 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04526938?term=NCT04526938&draw=2&rank=1title:</p><p>ide_number: G190192</p><p>nct_number: NCT04526938</p><p>sponsor_name: Medstar Health Research Institute</p><p>study_title: Clinical Outcomes, Radiation Dosage, and Quality of Life in Patients Treated With Fenestrated Stent Grafts for Complex Thoracoabdominal and Abdominal Aortic Aneurysms, Thoracoabdominal Aortic Aneurysms Secondary to Aortic Dissections</p>]]></description></item><item><title>G200329-NCT04729933</title><pubDate>Tue, 06 Apr 2021 06:17:52 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200329-nct04729933</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200329-nct04729933</guid><description><![CDATA[<p>approval_date: Thu, 01 Apr 2021 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04729933?term=NCT04729933&draw=2&rank=1title:</p><p>ide_number: G200329</p><p>nct_number: NCT04729933</p><p>sponsor_name: The Cleveland Clinic</p><p>study_title: Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip: The V-Wave Shunt MitraClip Study</p>]]></description></item><item><title>G200295-NCT04697004</title><pubDate>Tue, 06 Apr 2021 06:14:29 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200295-nct04697004</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200295-nct04697004</guid><description><![CDATA[<p>approval_date: Thu, 01 Apr 2021 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04697004?term=NCT04697004&draw=2&rank=1title:</p><p>ide_number: G200295</p><p>nct_number: NCT04697004</p><p>sponsor_name: Limacorporate S.p.a</p><p>study_title: A Randomized, Multi-Center, Prospective, Safety and Efficacy Study Comparing the Outcome of Total Reverse Shoulder Arthroplasty (RSA) With SMR Stemless Reverse vs SMR Reverse Shoulder System</p>]]></description></item><item><title>G180054-1-NCT03828136 </title><pubDate>Tue, 06 Apr 2021 06:11:11 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180054-1-nct03828136</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180054-1-nct03828136</guid><description><![CDATA[<p>approval_date: Fri, 26 Mar 2021 10:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03828136title:</p><p>ide_number: G180054</p><p>nct_number: NCT03828136</p><p>sponsor_name: Bio2 Technologies</p><p>study_title: Safety and Effectiveness of Bio2 Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion. A Randomized, Controlled, Non-inferiority, Pivotal Study</p>]]></description></item><item><title>G200210-NCT04734535  </title><pubDate>Tue, 30 Mar 2021 06:21:09 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200210-nct04734535</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200210-nct04734535</guid><description><![CDATA[<p>approval_date: Fri, 26 Mar 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04734535title:</p><p>ide_number: G200210</p><p>nct_number: NCT04734535</p><p>sponsor_name: Dilon Technologies </p><p>study_title: Prospective, randomized, controlled, multicenter, clinical investigation evaluation the safety of HEMOBLAST™ BELLOWS in spine surgery</p>]]></description></item><item><title>G190194-NCT04192630</title><pubDate>Tue, 30 Mar 2021 06:18:42 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190194-nct04192630</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190194-nct04192630</guid><description><![CDATA[<p>approval_date: Fri, 26 Mar 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT04192630title:</p><p>ide_number: G190194</p><p>nct_number: NCT04192630</p><p>sponsor_name: Precision for Medicine</p><p>study_title: A Study to Document the Safety and Effectiveness of a New Cohesive OVD When Compared to a Control OVD</p>]]></description></item><item><title>G200335-NCT04147884</title><pubDate>Tue, 30 Mar 2021 06:16:22 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200335-nct04147884</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200335-nct04147884</guid><description><![CDATA[<p>approval_date: Fri, 26 Mar 2021 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04147884title:</p><p>ide_number: G200335</p><p>nct_number: NCT04147884</p><p>sponsor_name: Boston Scientific Corporation </p><p>study_title: A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation: (Millipede Feasibility Study)</p>]]></description></item><item><title>G130005-NCT04252573</title><pubDate>Tue, 30 Mar 2021 06:13:08 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g130005-nct04252573</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g130005-nct04252573</guid><description><![CDATA[<p>approval_date: Fri, 26 Mar 2021 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04252573title:</p><p>ide_number: G130005</p><p>nct_number: NCT04252573</p><p>sponsor_name: Endologix</p><p>study_title: Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms</p>]]></description></item><item><title>G200259-NCT04612244</title><pubDate>Tue, 09 Mar 2021 06:31:45 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200259-nct04612244</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200259-nct04612244</guid><description><![CDATA[<p>approval_date: Thu, 04 Mar 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04612244title:</p><p>ide_number: G200259</p><p>nct_number: NCT04612244</p><p>sponsor_name: FARAPULSE, INC. </p><p>study_title: A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation</p>]]></description></item><item><title>G180015-NCT03603600</title><pubDate>Tue, 09 Mar 2021 06:27:29 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180015-nct03603600</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180015-nct03603600</guid><description><![CDATA[<p>approval_date: Thu, 04 Mar 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03603600title:</p><p>ide_number: G180015</p><p>nct_number: NCT03603600</p><p>sponsor_name: Bausch &#x26; Lomb Incorporated</p><p>study_title: A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction</p>]]></description></item><item><title>G200144-NCT04636073</title><pubDate>Tue, 09 Mar 2021 06:23:10 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200144-nct04636073</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200144-nct04636073</guid><description><![CDATA[<p>approval_date: Thu, 04 Mar 2021 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04636073title:</p><p>ide_number: G200144</p><p>nct_number: NCT04636073</p><p>sponsor_name: Pi-cardia</p><p>study_title: A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer</p>]]></description></item><item><title>G190171-NCT04505163</title><pubDate>Tue, 09 Mar 2021 06:20:23 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190171-nct04505163</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190171-nct04505163</guid><description><![CDATA[<p>approval_date: Thu, 04 Mar 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04505163title:</p><p>ide_number: G190171</p><p>nct_number: NCT04505163</p><p>sponsor_name: Dignity Health Medical Foundation</p><p>study_title: Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) - IDE Trial</p>]]></description></item><item><title>G200253-NCT04573881</title><pubDate>Tue, 09 Mar 2021 06:17:10 -0500</pubDate><link>https://www.cms.gov//https/wwwcmsgov/medicare/coverage/ide/approved-ide-studies/g200253-nct04573881</link><guid>https://www.cms.gov//https/wwwcmsgov/medicare/coverage/ide/approved-ide-studies/g200253-nct04573881</guid><description><![CDATA[<p>approval_date: Thu, 04 Mar 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04573881title:</p><p>ide_number: G200253</p><p>nct_number: NCT04573881</p><p>sponsor_name: HistoSonics, Inc.</p><p>study_title: The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER)</p>]]></description></item><item><title>G200143-NCT04658940</title><pubDate>Tue, 02 Mar 2021 06:41:50 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200143-nct04658940</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200143-nct04658940</guid><description><![CDATA[<p>approval_date: Thu, 25 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04658940?term=NCT04658940&draw=2&rank=1title:</p><p>ide_number: G200143</p><p>nct_number: NCT04658940</p><p>sponsor_name: Emerson Consultants, Inc.</p><p>study_title: AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)</p>]]></description></item><item><title>G190291-NCT04649255</title><pubDate>Tue, 02 Mar 2021 06:38:20 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190291-nct04649255</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190291-nct04649255</guid><description><![CDATA[<p>approval_date: Thu, 25 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04649255?term=NCT04649255&draw=2&rank=1title:</p><p>ide_number: G190291</p><p>nct_number: NCT04649255</p><p>sponsor_name: BlackSwan Vascular, Inc.</p><p>study_title: Liquid Embolization of Arterial Hemorrhages in the Peripheral Vasculature: The LAVA Study</p>]]></description></item><item><title>G200057-NCT04565795</title><pubDate>Tue, 02 Mar 2021 06:35:32 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200057-nct04565795</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200057-nct04565795</guid><description><![CDATA[<p>approval_date: Thu, 25 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04565795?term=URIPRENE&draw=2&rank=1title:</p><p>ide_number: G200057</p><p>nct_number: NCT04565795</p><p>sponsor_name: Adva-Tec</p><p>study_title: URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy</p>]]></description></item><item><title>G200060-NCT04403022  </title><pubDate>Tue, 02 Mar 2021 06:32:25 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200060-nct04403022</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200060-nct04403022</guid><description><![CDATA[<p>approval_date: Thu, 18 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04403022title:</p><p>ide_number: G200060</p><p>nct_number: NCT04403022</p><p>sponsor_name: Intuitive Surgical</p><p>study_title: A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease</p>]]></description></item><item><title>G200150-NCT04540302 </title><pubDate>Tue, 02 Mar 2021 06:29:40 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200150-nct04540302</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200150-nct04540302</guid><description><![CDATA[<p>approval_date: Thu, 18 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04540302title:</p><p>ide_number: G200150</p><p>nct_number: NCT04540302</p><p>sponsor_name: Merit Medical Systems, Inc.</p><p>study_title: Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODY™ Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients. The WAVE Study</p>]]></description></item><item><title>G170213-NCT04591392</title><pubDate>Tue, 16 Feb 2021 06:27:09 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170213-nct04591392</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170213-nct04591392</guid><description><![CDATA[<p>approval_date: Thu, 11 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04591392title:</p><p>ide_number: G170213</p><p>nct_number: NCT04591392</p><p>sponsor_name: Carag AG</p><p>study_title: Evaluation of the Safety and Efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to Treat Patients With Clinically Significant Secundum Atrial Septal Defect</p>]]></description></item><item><title>G200080-NCT04646057</title><pubDate>Tue, 16 Feb 2021 06:24:21 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200080-nct04646057</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200080-nct04646057</guid><description><![CDATA[<p>approval_date: Thu, 11 Feb 2021 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04646057title:</p><p>ide_number: G200080</p><p>nct_number: NCT04646057</p><p>sponsor_name: Surgical Innovation Associates, Inc.</p><p>study_title: The Safety and Effectiveness of DuraSorb® for Reinforcement in Patients Undergoing Prosthetic Breast Reconstruction</p>]]></description></item><item><title>G200183-NCT04563039</title><pubDate>Tue, 16 Feb 2021 06:20:53 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200183-nct04563039</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200183-nct04563039</guid><description><![CDATA[<p>approval_date: Thu, 11 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT04563039title:</p><p>ide_number: G200183</p><p>nct_number: NCT04563039</p><p>sponsor_name: Applaud Medical, Inc.</p><p>study_title: Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones</p>]]></description></item><item><title>G200147-NCT04511338</title><pubDate>Tue, 09 Feb 2021 06:36:20 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200147-nct04511338</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200147-nct04511338</guid><description><![CDATA[<p>approval_date: Thu, 04 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04511338title:</p><p>ide_number: G200147</p><p>nct_number: NCT04511338</p><p>sponsor_name: Fresenius Medical Care North America</p><p>study_title: A Randomized, Open Label, Cross-over Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ in End-Stage Renal Disease (ESRD) Subjects</p>]]></description></item><item><title>G200283-NCT04684862  </title><pubDate>Tue, 09 Feb 2021 06:32:47 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200283-nct04684862</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200283-nct04684862</guid><description><![CDATA[<p>approval_date: Thu, 04 Feb 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04684862title:</p><p>ide_number: G200283</p><p>nct_number: NCT04684862</p><p>sponsor_name: Ronald DeMatteo, M.D.</p><p>study_title: Combined Infusion System to Deliver Chemotherapy Regionally to the Liver</p>]]></description></item><item><title>G190296-NCT04668976 </title><pubDate>Tue, 02 Feb 2021 06:28:02 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190296-nct04668976</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190296-nct04668976</guid><description><![CDATA[<p>approval_date: Thu, 28 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04668976title:</p><p>ide_number: G190296</p><p>nct_number: NCT04668976</p><p>sponsor_name: Benaroya Research Institute</p><p>study_title: A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Advanced Colorectal Carcinoma or Cholangiocarcinoma</p>]]></description></item><item><title>G170070-NCT04562532  </title><pubDate>Tue, 02 Feb 2021 06:24:34 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170070-nct04562532</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170070-nct04562532</guid><description><![CDATA[<p>approval_date: Thu, 28 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04562532title:</p><p>ide_number: G170070</p><p>nct_number: NCT04562532</p><p>sponsor_name: MicroPort</p><p>study_title: Multicenter Randomized Assessment of the Firehawk™ Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial</p>]]></description></item><item><title>G200215-NCT04580914</title><pubDate>Tue, 26 Jan 2021 06:37:33 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200215-nct04580914</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200215-nct04580914</guid><description><![CDATA[<p>approval_date: Fri, 22 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04580914?term=StablePoint&draw=2&rank=1title:</p><p>ide_number: G200215</p><p>nct_number: NCT04580914</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation </p>]]></description></item><item><title>G190299-NCT04221815</title><pubDate>Tue, 26 Jan 2021 06:33:58 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190299-nct04221815</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190299-nct04221815</guid><description><![CDATA[<p>approval_date: Fri, 22 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04221815title:</p><p>ide_number: G190299</p><p>nct_number: NCT04221815</p><p>sponsor_name: Medstar Health Research Institute</p><p>study_title: IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)</p>]]></description></item><item><title>G170083-NCT04625660</title><pubDate>Tue, 26 Jan 2021 06:30:40 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170083-nct04625660</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170083-nct04625660</guid><description><![CDATA[<p>approval_date: Fri, 22 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04625660title:</p><p>ide_number: G170083</p><p>nct_number: NCT04625660</p><p>sponsor_name: PQ Bypass, Inc.</p><p>study_title: The DETOUR2 Continued Access Clinical Trial - The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - Continued Access Clinical Trial</p>]]></description></item><item><title>G170281-NCT04514562</title><pubDate>Tue, 26 Jan 2021 06:27:32 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170281-nct04514562</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170281-nct04514562</guid><description><![CDATA[<p>approval_date: Fri, 22 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04514562title:</p><p>ide_number: G170281</p><p>nct_number: NCT04514562</p><p>sponsor_name: Vesalio</p><p>study_title: Prospective, Open-Label, Multi-Center Single-Arm Trial Designed to Assess the Safety, Performance and Efficacy of the NeVa Stent Retriever in the Treatment of Large Vessel Occlusion Strokes</p>]]></description></item><item><title>G200097-NCT04489823</title><pubDate>Tue, 19 Jan 2021 17:18:51 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200097-nct0448982</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200097-nct0448982</guid><description><![CDATA[<p>approval_date: Fri, 15 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT04489823title:</p><p>ide_number: G200097</p><p>nct_number: NCT04489823</p><p>sponsor_name: Abbott Medical Devices</p><p>study_title: PARADIGM PARAvalvular Leak Closure With the Amplatzer Valvular Plug occluDer for Interventional Transcatheter Closure for PVL With Surgical bioloGical and Mechanical Heart Valve</p>]]></description></item><item><title>G150210-NCT04632160</title><pubDate>Tue, 19 Jan 2021 17:17:10 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150210-nct04632160</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150210-nct04632160</guid><description><![CDATA[<p>approval_date: Fri, 15 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04632160?term=NCT04632160&draw=2&rank=1title:</p><p>ide_number: G150210</p><p>nct_number: NCT04632160</p><p>sponsor_name: Corvia Medical</p><p>study_title: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure</p>]]></description></item><item><title>G180272-NCT04615182</title><pubDate>Tue, 19 Jan 2021 17:15:59 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180272-nct04615182</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180272-nct04615182</guid><description><![CDATA[<p>approval_date: Thu, 14 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04615182title:</p><p>ide_number: G180272</p><p>nct_number: NCT04615182</p><p>sponsor_name: TransMedics</p><p>study_title: The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)</p>]]></description></item><item><title>G200149-NCT04523350</title><pubDate>Tue, 19 Jan 2021 17:13:53 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200149-nct04523350</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200149-nct04523350</guid><description><![CDATA[<p>approval_date: Fri, 15 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04523350title:</p><p>ide_number: G200149</p><p>nct_number: NCT04523350</p><p>sponsor_name: Instylla, Inc.</p><p>study_title: Randomized Multi-Center, Subject and Evaluator Blinded, Parallel-Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared With Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study</p>]]></description></item><item><title>G200064-NCT04659213</title><pubDate>Tue, 19 Jan 2021 16:37:05 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200064-nct04659213</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200064-nct04659213</guid><description><![CDATA[<p>approval_date: Fri, 15 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04659213title:</p><p>ide_number: G200064</p><p>nct_number: NCT04659213</p><p>sponsor_name: S4 Medical</p><p>study_title: Esophagus Deviation and Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY</p>]]></description></item><item><title>G180106-NCT03851068</title><pubDate>Tue, 19 Jan 2021 16:35:36 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180106-nct03851068</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180106-nct03851068</guid><description><![CDATA[<p>approval_date: Fri, 15 Jan 2021 12:01:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03851068title:</p><p>ide_number: G180106</p><p>nct_number: NCT03851068</p><p>sponsor_name: Foldax, Inc</p><p>study_title: Early Feasibility Study for the Foldax Tria Aortic Heart Valve</p>]]></description></item><item><title>G190043-NCT04396379  </title><pubDate>Tue, 19 Jan 2021 16:34:33 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190043-nct04396379</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190043-nct04396379</guid><description><![CDATA[<p>approval_date: Fri, 08 Jan 2021 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04396379title:</p><p>ide_number: G190043</p><p>nct_number: NCT04396379</p><p>sponsor_name: Mitre Medical Corp.</p><p>study_title: ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency</p>]]></description></item><item><title>G190272-1-NCT04198701 </title><pubDate>Tue, 19 Jan 2021 16:33:11 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190272-1-nct04198701</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190272-1-nct04198701</guid><description><![CDATA[<p>approval_date: Fri, 08 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04198701title:</p><p>ide_number: G190272</p><p>nct_number: NCT04198701</p><p>sponsor_name: Medtronic Cardiac Rhythm and Heart Failure</p><p>study_title: Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF</p>]]></description></item><item><title>G180296-NCT04339699 </title><pubDate>Tue, 19 Jan 2021 16:31:29 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180296-nct04339699</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180296-nct04339699</guid><description><![CDATA[<p>approval_date: Fri, 08 Jan 2021 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04339699title:</p><p>ide_number: G180296</p><p>nct_number: NCT04339699</p><p>sponsor_name: HeartStitch.Com</p><p>study_title: STITCH - Prospective Multi Center Comparative Parallel Concurrent Study of the NobleStitch EL Compared to FDA Approved Amplatzer Occluder Device for Closure of Patent Foramen Ovale to Prevent Recurrent Ischemic Stroke</p>]]></description></item><item><title>G180132-NCT04630106  </title><pubDate>Mon, 11 Jan 2021 13:19:51 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180132-nct04630106</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180132-nct04630106</guid><description><![CDATA[<p>approval_date: Mon, 21 Dec 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04630106title:</p><p>ide_number: G180132</p><p>nct_number: NCT04630106</p><p>sponsor_name: NEVRO</p><p>study_title: Senza Spinal Cord Stimulation (SCS) System </p>]]></description></item><item><title>G200219-NCT04592445</title><pubDate>Tue, 15 Dec 2020 06:28:31 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200219-nct04592445</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200219-nct04592445</guid><description><![CDATA[<p>approval_date: Thu, 10 Dec 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04592445title:</p><p>ide_number: G200219</p><p>nct_number: NCT04592445</p><p>sponsor_name: Axon Therapies, Inc.</p><p>study_title: ENDOVASCULAR ABLATION OF THE RIGHT GREATER SPLANCHNIC NERVE IN Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF: Feasibility Study: Randomized Controlled Feasibility Trial- Rebalance HF Study</p>]]></description></item><item><title>G200074-NCT04408430</title><pubDate>Tue, 15 Dec 2020 06:25:40 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200074-nct04408430</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200074-nct04408430</guid><description><![CDATA[<p>approval_date: Thu, 10 Dec 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04408430title:</p><p>ide_number: G200074</p><p>nct_number: NCT04408430</p><p>sponsor_name: Mayra Guerrero</p><p>study_title: The Safety and Effectiveness of the SAPIEN 3 and SAPIEN 3 Ultra Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.</p>]]></description></item><item><title>G200100-NCT04647253</title><pubDate>Tue, 15 Dec 2020 06:21:28 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200100-nct04647253</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200100-nct04647253</guid><description><![CDATA[<p>approval_date: Thu, 10 Dec 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04647253title:</p><p>ide_number: G200100</p><p>nct_number: NCT04647253</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: Agent Monorail Paclitaxel-Coated PTCA Balloon Catheter</p>]]></description></item><item><title>G140049-NCT04028674</title><pubDate>Tue, 08 Dec 2020 06:15:01 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g140049-nct04028674</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g140049-nct04028674</guid><description><![CDATA[<p>approval_date: Fri, 06 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04028674?term=NCT04028674title:</p><p>ide_number: G140049</p><p>nct_number: NCT04028674</p><p>sponsor_name: Vanderbilt University Medical Center</p><p>study_title: Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx</p>]]></description></item><item><title>G200111-NCT04472091 </title><pubDate>Tue, 08 Dec 2020 06:11:13 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200111-nct04472091</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200111-nct04472091</guid><description><![CDATA[<p>approval_date: Fri, 06 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04472091?term=NCT04472091title:</p><p>ide_number: G200111</p><p>nct_number: NCT04472091</p><p>sponsor_name: Andrew Picel</p><p>study_title: Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain</p>]]></description></item><item><title>G160104-NCT04419779</title><pubDate>Tue, 08 Dec 2020 06:08:19 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160104-nct04419779</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160104-nct04419779</guid><description><![CDATA[<p>approval_date: Thu, 03 Dec 2020 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04419779?term=NCT04419779title:</p><p>ide_number: G160104</p><p>nct_number: NCT04419779</p><p>sponsor_name: Fractyl Laboratories, Inc.</p><p>study_title: A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy</p>]]></description></item><item><title>G200163-NCT04483102</title><pubDate>Tue, 08 Dec 2020 06:05:27 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200163-nct04483102</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200163-nct04483102</guid><description><![CDATA[<p>approval_date: Thu, 03 Dec 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04483102?term=NCT04483102title:</p><p>ide_number: G200163</p><p>nct_number: NCT04483102</p><p>sponsor_name: Washington University School of Medicine</p><p>study_title: A Prospective, Single-Center, Non-Randomized, Clinical Trial of Transplantation of Discarded Livers Using Normothermic Machine Perfusion (NMP)</p>]]></description></item><item><title>G190178-NCT04129229</title><pubDate>Tue, 08 Dec 2020 06:02:38 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190178-nct04129229</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190178-nct04129229</guid><description><![CDATA[<p>approval_date: Fri, 20 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04129229?term=NCT04129229&draw=2&rank=1title:</p><p>ide_number: G190178</p><p>nct_number: NCT04129229</p><p>sponsor_name: Linguaflex, Inc.</p><p>study_title: Non-Randomized, Multi-Site, Single-Arm Study of the LinguaFlex™ Tongue Retractor (LTR) for the Treatment of Moderate to Severe Obstructive Sleep Apnea and Snoring in Adult Subjects</p>]]></description></item><item><title>G150249-NCT04331769</title><pubDate>Tue, 24 Nov 2020 07:37:31 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150249-nct04331769</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150249-nct04331769</guid><description><![CDATA[<p>approval_date: Thu, 12 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04331769title:</p><p>ide_number: G150249</p><p>nct_number: NCT04331769</p><p>sponsor_name: Ancora Heart, Inc. </p><p>study_title: Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study</p>]]></description></item><item><title>G200239-NCT04564885</title><pubDate>Tue, 24 Nov 2020 07:35:08 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200239-nct04564885</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200239-nct04564885</guid><description><![CDATA[<p>approval_date: Thu, 12 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04564885title:</p><p>ide_number: G200239</p><p>nct_number: NCT04564885</p><p>sponsor_name: Spineart USA </p><p>study_title: A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA®C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at Two Contiguous Levels</p>]]></description></item><item><title>G160110-NCT04570228  </title><pubDate>Tue, 24 Nov 2020 07:32:55 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160110-nct04570228</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160110-nct04570228</guid><description><![CDATA[<p>approval_date: Thu, 19 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04570228title:</p><p>ide_number: G160110</p><p>nct_number: NCT04570228</p><p>sponsor_name: SoniVie Inc. </p><p>study_title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension</p>]]></description></item><item><title>G200069-NCT04108481  </title><pubDate>Tue, 24 Nov 2020 07:30:13 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200069-nct04108481</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200069-nct04108481</guid><description><![CDATA[<p>approval_date: Thu, 19 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04108481title:</p><p>ide_number: G200069</p><p>nct_number: NCT04108481</p><p>sponsor_name: University of Iowa</p><p>study_title: Immunotherapy Combined With Yttrium-90 RadioEmbolization in the Treatment of Colorectal Cancer With Liver Metastases [iRE-C - Clinical Trial]</p>]]></description></item><item><title>G200053-NCT03685578  </title><pubDate>Tue, 24 Nov 2020 07:25:10 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200053-nct03685578</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200053-nct03685578</guid><description><![CDATA[<p>approval_date: Thu, 19 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03685578title:</p><p>ide_number: G200053</p><p>nct_number: NCT03685578</p><p>sponsor_name: Neuravi Limited</p><p>study_title: Embotrap eXtraction &#x26; Clot EvaLuation &#x26; Lesion Evaluation for NeuroThrombectomy</p>]]></description></item><item><title>G190289-NCT04482062</title><pubDate>Tue, 24 Nov 2020 07:22:27 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190289-nct04482062</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190289-nct04482062</guid><description><![CDATA[<p>approval_date: Thu, 19 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04482062title:</p><p>ide_number: G190289</p><p>nct_number: NCT04482062</p><p>sponsor_name: Edwards Lifesciences </p><p>study_title: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device</p>]]></description></item><item><title>G190068-NCT03868618  </title><pubDate>Tue, 24 Nov 2020 07:19:33 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190068-nct03868618</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190068-nct03868618</guid><description><![CDATA[<p>approval_date: Fri, 06 Nov 2020 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03868618title:</p><p>ide_number: G190068</p><p>nct_number: NCT03868618</p><p>sponsor_name: Nyxoah S.A. </p><p>study_title: A Multicenter Study to Assess the Safety and Effectiveness of the Genio Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Adults Subjects</p>]]></description></item><item><title>G190030-NCT04580160 </title><pubDate>Thu, 12 Nov 2020 06:22:38 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190030-nct04580160</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190030-nct04580160</guid><description><![CDATA[<p>approval_date: Fri, 30 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04580160title:</p><p>ide_number: G190030</p><p>nct_number: NCT04580160</p><p>sponsor_name: Vesper Medical, Inc.</p><p>study_title: Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System</p>]]></description></item><item><title>G190038-NCT04410146</title><pubDate>Thu, 12 Nov 2020 06:19:13 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190038-nct04410146</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190038-nct04410146</guid><description><![CDATA[<p>approval_date: Fri, 30 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04410146title:</p><p>ide_number: G190038</p><p>nct_number: NCT04410146</p><p>sponsor_name: Balt USA</p><p>study_title: The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)</p>]]></description></item><item><title>G200105-NCT04471909  </title><pubDate>Thu, 12 Nov 2020 06:13:23 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200105-nct04471909</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200105-nct04471909</guid><description><![CDATA[<p>approval_date: Fri, 30 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04471909title:</p><p>ide_number: G200105</p><p>nct_number: NCT04471909</p><p>sponsor_name: Endospan Ltd.</p><p>study_title: A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch</p>]]></description></item><item><title>G200182-NCT04520776  </title><pubDate>Tue, 10 Nov 2020 11:59:06 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200182-nct04520776-0</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200182-nct04520776-0</guid><description><![CDATA[<p>approval_date: Fri, 30 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04520776title:</p><p>ide_number: G200182</p><p>nct_number: NCT04520776</p><p>sponsor_name: Spineart USA</p><p>study_title: A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA®C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at a Single Level</p>]]></description></item><item><title>G190266-NCT04397185</title><pubDate>Tue, 27 Oct 2020 16:48:28 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190266-nct04397185</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190266-nct04397185</guid><description><![CDATA[<p>approval_date: Thu, 15 Oct 2020 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04397185title:</p><p>ide_number: G190266</p><p>nct_number: NCT04397185</p><p>sponsor_name: CairnSurgical, Inc.</p><p>study_title: Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer</p>]]></description></item><item><title>G200182-NCT04520776</title><pubDate>Tue, 27 Oct 2020 16:46:25 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200182-nct04520776</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200182-nct04520776</guid><description><![CDATA[<p>approval_date: Thu, 15 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04520776title:</p><p>ide_number: G200182</p><p>nct_number: NCT04520776</p><p>sponsor_name: Spineart USA</p><p>study_title: A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA®C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at a Single Level</p>]]></description></item><item><title>G200008-NCT03852420</title><pubDate>Tue, 27 Oct 2020 16:44:16 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200008-nct03852420</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200008-nct03852420</guid><description><![CDATA[<p>approval_date: Thu, 15 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03852420title:</p><p>ide_number: G200008</p><p>nct_number: NCT03852420</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: Safety and Effectiveness Evaluation of Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation</p>]]></description></item><item><title>G200096-NCT04537312 </title><pubDate>Tue, 27 Oct 2020 16:41:32 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200096-nct04537312</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200096-nct04537312</guid><description><![CDATA[<p>approval_date: Thu, 22 Oct 2020 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04537312title:</p><p>ide_number: G200096 </p><p>nct_number: NCT04537312 </p><p>sponsor_name: Ko Un Park</p><p>study_title: Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)</p>]]></description></item><item><title>G200158-NCT04546555  </title><pubDate>Tue, 27 Oct 2020 16:37:48 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200158-nct04546555</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200158-nct04546555</guid><description><![CDATA[<p>approval_date: Thu, 22 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04546555title:</p><p>ide_number: G200158  </p><p>nct_number: NCT04546555</p><p>sponsor_name: Medtronic</p><p>study_title: Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction</p>]]></description></item><item><title>G200104-NCT04502745</title><pubDate>Tue, 13 Oct 2020 06:44:14 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200104-nct04502745</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200104-nct04502745</guid><description><![CDATA[<p>approval_date: Thu, 08 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04502745?term=MICAS&draw=2&rank=1title:</p><p>ide_number: G200104</p><p>nct_number: NCT04502745</p><p>sponsor_name: Mayo Clinic </p><p>study_title: A Pilot Study of Endoscope-assisted, Minimally-invasive Cortical Access System (MICAS) for Chronic Subdural Evacuation</p>]]></description></item><item><title>G180090-NCT04469231</title><pubDate>Tue, 13 Oct 2020 06:41:19 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180090-nct04469231</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180090-nct04469231</guid><description><![CDATA[<p>approval_date: Thu, 08 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04469231?term=Synergy+Disc&draw=2&rank=1title:</p><p>ide_number: G180090</p><p>nct_number: NCT04469231</p><p>sponsor_name: Synergy Disc Replacement Ltd</p><p>study_title: A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).</p>]]></description></item><item><title>G150107-NCT04468334</title><pubDate>Tue, 13 Oct 2020 06:37:30 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g150107-nct04468334</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g150107-nct04468334</guid><description><![CDATA[<p>approval_date: Thu, 08 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04468334?term=NCT04468334&draw=2&rank=1title:</p><p>ide_number: G150107</p><p>nct_number: NCT04468334</p><p>sponsor_name: AtriCure, Inc. </p><p>study_title: Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT® Suture Delivery Device (Appendix 16 to Ongoing Investigation)</p>]]></description></item><item><title>G200113-NCT04471844</title><pubDate>Tue, 13 Oct 2020 06:33:51 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200113-nct04471844</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200113-nct04471844</guid><description><![CDATA[<p>approval_date: Thu, 01 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04471844?term=NCT04471844&draw=1&rank=1title:</p><p>ide_number: G200113  </p><p>nct_number: NCT04471844  </p><p>sponsor_name: NovoCure GmbH </p><p>study_title: EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma</p>]]></description></item><item><title>G170079-NCT03353896  </title><pubDate>Tue, 13 Oct 2020 06:30:30 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170079-nct03353896</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170079-nct03353896</guid><description><![CDATA[<p>approval_date: Thu, 01 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03353896title:</p><p>ide_number: G170079  </p><p>nct_number: NCT03353896  </p><p>sponsor_name: University of Southern California </p><p>study_title: Pilot Trial of NovoTTF -200A (TTFields) in Patients With Newly Diagnosed High Risk Oligodendrogliomas</p>]]></description></item><item><title>G200124-NCT04437862  </title><pubDate>Tue, 13 Oct 2020 06:27:19 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200124-nct04437862</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200124-nct04437862</guid><description><![CDATA[<p>approval_date: Thu, 01 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04437862?term=NCT04437862&draw=2&rank=1title:</p><p>ide_number: G200124  </p><p>nct_number: NCT04437862  </p><p>sponsor_name: MIVI Neuroscience, Inc.</p><p>study_title: A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study</p>]]></description></item><item><title> G190104-NCT04251715 </title><pubDate>Tue, 13 Oct 2020 06:23:26 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190104-nct04251715</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190104-nct04251715</guid><description><![CDATA[<p>approval_date: Thu, 01 Oct 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04251715?term=NCT04251715&draw=2&rank=1title:</p><p>ide_number: G190104  </p><p>nct_number: NCT04251715  </p><p>sponsor_name: OHSU Knight Cancer Institute</p><p>study_title: A Phase II Study of Induction Systemic mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone Given Concurrently With Systemic mFOLFIRI as a First-Line Therapy in Patients With Unresectable Liver-Dominant Intrahepatic Cholangiocarcinoma</p>]]></description></item><item><title>G150266-NCT04319887 </title><pubDate>Wed, 30 Sep 2020 13:27:38 -0400</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g150266-nct04319887</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g150266-nct04319887</guid><description><![CDATA[<p>approval_date: Thu, 11 Jun 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04319887?term=NCT04319887&draw=2&rank=1title:</p><p>ide_number: G150266</p><p>nct_number: NCT04319887</p><p>sponsor_name: saluda MEDICAL </p><p>study_title: Evoke Spinal Cord Stimulator System</p>]]></description></item><item><title>G180244-1-NCT04029337  </title><pubDate>Tue, 15 Sep 2020 09:27:11 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180244-1-nct04029337</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180244-1-nct04029337</guid><description><![CDATA[<p>approval_date: Wed, 09 Sep 2020 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04029337title:</p><p>ide_number: G180244</p><p>nct_number: NCT04029337</p><p>sponsor_name: HighLife SAS</p><p>study_title: An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System</p>]]></description></item><item><title>G190316-NCT04379700  </title><pubDate>Tue, 15 Sep 2020 09:25:11 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190316-nct04379700</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190316-nct04379700</guid><description><![CDATA[<p>approval_date: Wed, 09 Sep 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04379700title:</p><p>ide_number: G190316</p><p>nct_number: NCT04379700</p><p>sponsor_name: NYU Langone Health</p><p>study_title: Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis</p>]]></description></item><item><title>G190263-NCT04402632 </title><pubDate>Tue, 15 Sep 2020 06:27:56 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190263-nct04402632</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190263-nct04402632</guid><description><![CDATA[<p>approval_date: Wed, 02 Sep 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04402632title:</p><p>ide_number: G190263</p><p>nct_number: NCT04402632</p><p>sponsor_name: Medtronic Neurovascular Clinical Affairs</p><p>study_title: A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)</p>]]></description></item><item><title>G200067-NCT04375332 </title><pubDate>Tue, 15 Sep 2020 06:25:35 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200067-nct04375332</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200067-nct04375332</guid><description><![CDATA[<p>approval_date: Wed, 02 Sep 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04375332title:</p><p>ide_number: G200067</p><p>nct_number: NCT04375332</p><p>sponsor_name: Edwards Lifesciences</p><p>study_title: Harpoon Beating Mitral Valve Repair System</p>]]></description></item><item><title>G180232-NCT03995667  </title><pubDate>Tue, 15 Sep 2020 06:23:35 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180232-nct03995667</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180232-nct03995667</guid><description><![CDATA[<p>approval_date: Wed, 02 Sep 2020 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03995667title:</p><p>ide_number: G180232</p><p>nct_number: NCT03995667</p><p>sponsor_name: OHSU Knight Cancer Institute</p><p>study_title: Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer</p>]]></description></item><item><title>G190156-NCT03259763</title><pubDate>Tue, 11 Aug 2020 07:22:34 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190156-nct03259763</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190156-nct03259763</guid><description><![CDATA[<p>approval_date: Fri, 07 Aug 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03259763?term=NCT03259763&draw=2&rank=1title:</p><p>ide_number: G190156</p><p>nct_number: NCT03259763</p><p>sponsor_name: Johns Hopkins University </p><p>study_title: EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial</p>]]></description></item><item><title>G190293-NCT04356040</title><pubDate>Tue, 11 Aug 2020 07:21:07 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190293-nct04356040</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190293-nct04356040</guid><description><![CDATA[<p>approval_date: Fri, 07 Aug 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04356040?term=NCT04356040&draw=2&rank=1title:</p><p>ide_number: G190293</p><p>nct_number: NCT04356040</p><p>sponsor_name: Abbott Medical Devices </p><p>study_title: Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation</p>]]></description></item><item><title>G190065-NCT03892980</title><pubDate>Tue, 11 Aug 2020 07:19:21 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190065-nct03892980</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190065-nct03892980</guid><description><![CDATA[<p>approval_date: Fri, 31 Jul 2020 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03892980?term=NCT03892980&draw=2&rank=1title:</p><p>ide_number: G190065</p><p>nct_number: NCT03892980</p><p>sponsor_name: Intuitive Surgical </p><p>study_title: A Prospective, Multicenter Investigation of the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures</p>]]></description></item><item><title>G200036-NCT04409158  </title><pubDate>Tue, 11 Aug 2020 07:17:32 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200036-nct04409158</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200036-nct04409158</guid><description><![CDATA[<p>approval_date: Thu, 23 Jul 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04409158?term=NCT04409158&draw=2&rank=1title:</p><p>ide_number: G200036</p><p>nct_number: NCT04409158</p><p>sponsor_name: Vascular Medcure, Inc.</p><p>study_title: CAPERE Embolectomy System</p>]]></description></item><item><title>G090207-NCT04198012 </title><pubDate>Tue, 11 Aug 2020 07:15:59 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g090207-nct04198012</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g090207-nct04198012</guid><description><![CDATA[<p>approval_date: Thu, 23 Jul 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04198012title:</p><p>ide_number: G090207</p><p>nct_number: NCT04198012</p><p>sponsor_name: Deka Research and Development </p><p>study_title: An Open Label Study to HemoCare™ Hemodialysis System for Home Hemodialysis Prior to Market Authorization</p>]]></description></item><item><title>G200002-NCT04282148</title><pubDate>Tue, 16 Jun 2020 07:28:06 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200002-nct04282148</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200002-nct04282148</guid><description><![CDATA[<p>approval_date: Thu, 11 Jun 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04282148title:</p><p>ide_number: G200002</p><p>nct_number: NCT04282148</p><p>sponsor_name: Abbott Medical Devices</p><p>study_title: A Clinical Investigation to Assess the Abbott Next Generation Drug Eluting Stent 48mm Everolimus Eluting Coronary Stent System (EECSS) in Treatment of de Novo Native Coronary Artery Disease</p>]]></description></item><item><title>G190319-NCT04391803</title><pubDate>Tue, 16 Jun 2020 07:26:14 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190319-nct04391803</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190319-nct04391803</guid><description><![CDATA[<p>approval_date: Thu, 11 Jun 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04391803title:</p><p>ide_number: G190319</p><p>nct_number: NCT04391803</p><p>sponsor_name: Medtronic Neurovascular Clinical Affairs </p><p>study_title: EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms Not Amenable To Clipping And coilinG With the Pipeline™ Vantage Embolization Device (VANTAGE)</p>]]></description></item><item><title>G180212-NCT03521804</title><pubDate>Tue, 16 Jun 2020 07:24:32 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180212-nct03521804</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180212-nct03521804</guid><description><![CDATA[<p>approval_date: Thu, 11 Jun 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03521804title:</p><p>ide_number: G180212</p><p>nct_number: NCT03521804</p><p>sponsor_name: SoundBite Medical Solutions, Inc.</p><p>study_title: A Single-Arm Study to Assess the Safety and Efficacy of the SoundBite™ Crossing System With ACTIVE Wire in Coronary Chronic Total Occlusions (the ACTIVE Trial).</p>]]></description></item><item><title>G190246-NCT04212780</title><pubDate>Tue, 19 May 2020 06:35:56 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190246-nct04212780</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190246-nct04212780</guid><description><![CDATA[<p>approval_date: Thu, 14 May 2020 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04212780title:</p><p>ide_number: G190246</p><p>nct_number: NCT04212780</p><p>sponsor_name: University of Florida </p><p>study_title: Dual Lead Thalamic DBR-DBS Interface for Closed Loop Control of Severe Essential Tremor</p>]]></description></item><item><title>G180184 -NCT04117295</title><pubDate>Tue, 12 May 2020 06:41:50 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180184-nct04117295</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180184-nct04117295</guid><description><![CDATA[<p>approval_date: Thu, 07 May 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04117295title:</p><p>ide_number: G180184 </p><p>nct_number: NCT04117295</p><p>sponsor_name: Carmat SA </p><p>study_title: Carmat Total Artificial Heart Early Feasibility Study</p>]]></description></item><item><title>G200007-NCT04201132</title><pubDate>Tue, 05 May 2020 07:02:35 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200007-nct04201132</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200007-nct04201132</guid><description><![CDATA[<p>approval_date: Thu, 30 Apr 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04201132title:</p><p>ide_number: G200007</p><p>nct_number: NCT04201132</p><p>sponsor_name: Contego Medical, LLC </p><p>study_title: Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1 Delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter and a Novel Carotid Stent II</p>]]></description></item><item><title>G170080-NCT03361995</title><pubDate>Tue, 28 Apr 2020 07:23:21 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g170080-nct03361995</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g170080-nct03361995</guid><description><![CDATA[<p>approval_date: Thu, 23 Apr 2020 05:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03361995?term=NCT03361995&draw=2&rank=1title:</p><p>ide_number: G170080</p><p>nct_number: NCT03361995</p><p>sponsor_name: ZOLL Circulation, Inc., USA </p><p>study_title: STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients With Acute Myocardial Infarction (Phase A)</p>]]></description></item><item><title>G190206-NCT04189913</title><pubDate>Tue, 28 Apr 2020 07:20:03 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190206-nct04189913</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190206-nct04189913</guid><description><![CDATA[<p>approval_date: Thu, 23 Apr 2020 05:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04189913title:</p><p>ide_number: G190206</p><p>nct_number: NCT04189913</p><p>sponsor_name: Palette Life Sciences</p><p>study_title: Randomized Trial of Barrigel® to increase distance between the prostate and rectum to decrease rectal dose in patients receiving definitive radiation therapy for localized prostate cancer</p>]]></description></item><item><title>G190167-NCT04184973</title><pubDate>Tue, 21 Apr 2020 06:44:12 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190167-nct04184973</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190167-nct04184973</guid><description><![CDATA[<p>approval_date: Wed, 15 Apr 2020 05:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04184973title:</p><p>ide_number: G190167</p><p>nct_number: NCT04184973</p><p>sponsor_name: Colospan</p><p>study_title: CG- 100 Intraluminal ByPass Device</p>]]></description></item><item><title>G190277-NCT04248283</title><pubDate>Tue, 21 Apr 2020 06:41:04 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190277-nct04248283</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190277-nct04248283</guid><description><![CDATA[<p>approval_date: Wed, 15 Apr 2020 05:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04248283title:</p><p>ide_number: G190277</p><p>nct_number: NCT04248283</p><p>sponsor_name: Uromedica</p><p>study_title: A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency</p>]]></description></item><item><title>G150081-NCT04240639  </title><pubDate>Tue, 07 Apr 2020 07:44:33 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150081-nct04240639</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g150081-nct04240639</guid><description><![CDATA[<p>approval_date: Fri, 03 Apr 2020 11:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04240639title:</p><p>ide_number: G150081</p><p>nct_number: NCT04240639</p><p>sponsor_name: Nanospectra Biosciences, Inc. </p><p>study_title: A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue</p>]]></description></item><item><title>G170289-1-NCT03441971  </title><pubDate>Tue, 07 Apr 2020 07:42:19 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g170289-1-nct03441971</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g170289-1-nct03441971</guid><description><![CDATA[<p>approval_date: Thu, 02 Apr 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03441971title:</p><p>ide_number: G170289</p><p>nct_number: NCT03441971</p><p>sponsor_name: Gore</p><p>study_title: GORE PV1 Device </p>]]></description></item><item><title>G200009-NCT04248868</title><pubDate>Tue, 07 Apr 2020 07:40:03 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200009-nct04248868</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g200009-nct04248868</guid><description><![CDATA[<p>approval_date: Thu, 02 Apr 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04248868title:</p><p>ide_number: G200009</p><p>nct_number: NCT04248868</p><p>sponsor_name: Thrombolex, Inc. </p><p>study_title: Recombinant tPA by Endovascular Administration for the treatment of Submassive pulmonary embolism using pharmaco-mechanical Catheter directed thrombolysis for the redUction of thrombus burdEn - The RESCUE Study</p>]]></description></item><item><title>G180199-NCT03639051</title><pubDate>Tue, 07 Apr 2020 07:36:42 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180199-nct03639051</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180199-nct03639051</guid><description><![CDATA[<p>approval_date: Thu, 02 Apr 2020 11:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03639051title:</p><p>ide_number: G180199</p><p>nct_number: NCT03639051</p><p>sponsor_name: Nuvaira, Inc. </p><p>study_title: A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment With the Nuvaira™ Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD)</p>]]></description></item><item><title>G170234-NCT03873714</title><pubDate>Tue, 31 Mar 2020 06:55:07 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g170234-nct03873714</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g170234-nct03873714</guid><description><![CDATA[<p>approval_date: Thu, 26 Mar 2020 05:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03873714?term=NCT03873714&draw=2&rank=1title:</p><p>ide_number: G170234</p><p>nct_number: NCT03873714</p><p>sponsor_name: Medtronic Neurovascular Clinical Affairs </p><p>study_title: A Study of the Pipeline™ Vantage Embolization Device With Shield Technology™ for Endovascular Treatment of Wide-Necked Intracranial Aneurysms</p>]]></description></item><item><title>G190111-NCT04227899</title><pubDate>Tue, 31 Mar 2020 06:52:31 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190111-nct04227899</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190111-nct04227899</guid><description><![CDATA[<p>approval_date: Thu, 26 Mar 2020 05:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04227899title:</p><p>ide_number: G190111</p><p>nct_number: NCT04227899</p><p>sponsor_name: Abbott Medical Devices</p><p>study_title: LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial </p>]]></description></item><item><title>G190253-NCT04243889</title><pubDate>Tue, 24 Mar 2020 08:35:41 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190253-nct04243889</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190253-nct04243889</guid><description><![CDATA[<p>approval_date: Thu, 19 Mar 2020 14:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04243889title:</p><p>ide_number: G190253</p><p>nct_number: NCT04243889</p><p>sponsor_name: The University of Texas Health Science Center, Houston </p><p>study_title: Early Feasibility Study of Fetoscopic Myelomeningocele Repair Using a Cryopreserved Human Umbilical Cord Allograft (NEOX Cord 1K®) as a Meningeal Patch</p>]]></description></item><item><title>G190119-NCT04241224</title><pubDate>Tue, 24 Mar 2020 08:32:23 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190119-nct04241224</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190119-nct04241224</guid><description><![CDATA[<p>approval_date: Thu, 19 Mar 2020 14:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04241224title:</p><p>ide_number: G190119</p><p>nct_number: NCT04241224</p><p>sponsor_name: Ra Medical Systems </p><p>study_title: A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages</p>]]></description></item><item><title>G190160-NCT04144972</title><pubDate>Wed, 18 Mar 2020 06:30:23 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190160-nct04144972</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190160-nct04144972</guid><description><![CDATA[<p>approval_date: Wed, 15 Jan 2020 10:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04144972title:</p><p>ide_number: G190160</p><p>nct_number: NCT04144972</p><p>sponsor_name: University of California, San Francisco </p><p>study_title: Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain Using Summit RC+S</p>]]></description></item><item><title>G180213-1-NCT03836079 </title><pubDate>Tue, 17 Mar 2020 07:08:35 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180213-1-nct03836079</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180213-1-nct03836079</guid><description><![CDATA[<p>approval_date: Thu, 05 Mar 2020 10:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03836079title:</p><p>ide_number: G180213</p><p>nct_number: NCT03836079</p><p>sponsor_name: preCARDIA Inc </p><p>study_title: Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure</p>]]></description></item><item><title>G160020-1-NCT02322840</title><pubDate>Tue, 17 Mar 2020 07:06:01 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160020-1-nct02322840</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160020-1-nct02322840</guid><description><![CDATA[<p>approval_date: Thu, 12 Mar 2020 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02322840title:</p><p>ide_number: G160020</p><p>nct_number: NCT02322840</p><p>sponsor_name: Medtronic</p><p>study_title: Intrepid Transcatheter Mitral Valve Replacement System</p>]]></description></item><item><title>G190254-NCT03940196</title><pubDate>Tue, 17 Mar 2020 06:59:31 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190254-nct03940196</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190254-nct03940196</guid><description><![CDATA[<p>approval_date: Thu, 05 Mar 2020 10:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03940196title:</p><p>ide_number: G190254</p><p>nct_number: NCT03940196</p><p>sponsor_name: NovoCure Ltd. </p><p>study_title: ENGOT-ov50 / GOG-3029 / INNOVATE-3: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer</p>]]></description></item><item><title>G190234-NCT04182620 </title><pubDate>Tue, 17 Mar 2020 06:55:35 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190234-nct04182620</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190234-nct04182620</guid><description><![CDATA[<p>approval_date: Thu, 05 Mar 2020 10:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04182620title:</p><p>ide_number: G190234</p><p>nct_number: NCT04182620</p><p>sponsor_name: Vivek Reddy </p><p>study_title: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study</p>]]></description></item><item><title>G190197-NCT04241679</title><pubDate>Tue, 17 Mar 2020 06:51:35 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190197-nct04241679</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190197-nct04241679</guid><description><![CDATA[<p>approval_date: Thu, 12 Mar 2020 10:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04241679title:</p><p>ide_number: G190197</p><p>nct_number: NCT04241679</p><p>sponsor_name: Washington University School of Medicine </p><p>study_title: Feasibility of Auditory Nerve Test System for Optimization of Simultaneous Translabyrinthine Vestibular Schwannoma Resection With Cochlear Implantation</p>]]></description></item><item><title>G190084-NCT04195568</title><pubDate>Tue, 17 Mar 2020 06:49:02 -0400</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190084-nct04195568</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190084-nct04195568</guid><description><![CDATA[<p>approval_date: Thu, 05 Mar 2020 10:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04195568title:</p><p>ide_number: G190084</p><p>nct_number: NCT04195568</p><p>sponsor_name: Stryker Neurovascular </p><p>study_title: EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System </p>]]></description></item><item><title>G160009-NCT03184454  </title><pubDate>Tue, 03 Mar 2020 07:59:08 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160009-nct03184454</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g160009-nct03184454</guid><description><![CDATA[<p>approval_date: Thu, 27 Feb 2020 10:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03184454?term=NCT03184454&draw=2&rank=1title:</p><p>ide_number: G160009</p><p>nct_number: NCT03184454</p><p>sponsor_name: Massachusetts General Hospital </p><p>study_title: Combined Cortical and Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder</p>]]></description></item><item><title>G180160-NCT04073563  </title><pubDate>Tue, 03 Mar 2020 07:57:02 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180160-nct04073563</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180160-nct04073563</guid><description><![CDATA[<p>approval_date: Thu, 27 Feb 2020 10:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04073563?term=capstone&draw=2&rank=1title:</p><p>ide_number: G180160</p><p>nct_number: NCT04073563</p><p>sponsor_name: Medtronic Spinal and Biologics</p><p>study_title: Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft and The Capstone™ Spinal System With Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine</p>]]></description></item><item><title>G190039-NCT03893370 </title><pubDate>Tue, 03 Mar 2020 07:52:42 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190039-nct03893370</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190039-nct03893370</guid><description><![CDATA[<p>approval_date: Thu, 27 Feb 2020 10:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03893370title:</p><p>ide_number: G190039</p><p>nct_number: NCT03893370</p><p>sponsor_name: CSA Medical, Inc. </p><p>study_title: A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis</p>]]></description></item><item><title>G180070-1-NCT03705000  </title><pubDate>Tue, 03 Mar 2020 07:48:02 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180070-1-nct03705000</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180070-1-nct03705000</guid><description><![CDATA[<p>approval_date: Thu, 27 Feb 2020 10:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03705000title:</p><p>ide_number: G180070</p><p>nct_number: NCT03705000</p><p>sponsor_name: Alon Kahana </p><p>study_title: Safety and Efficacy of the Slit Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction</p>]]></description></item><item><title>G190289-NCT04221490</title><pubDate>Tue, 25 Feb 2020 08:35:51 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190289-nct04221490</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190289-nct04221490</guid><description><![CDATA[<p>approval_date: Wed, 19 Feb 2020 01:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04221490?term=NCT04221490&draw=2&rank=1title:</p><p>ide_number: G190289</p><p>nct_number: NCT04221490</p><p>sponsor_name: Edwards Lifesciences</p><p>study_title: EVOQUE TR EFS </p>]]></description></item><item><title>G140192-NCT04186221 </title><pubDate>Tue, 25 Feb 2020 08:33:54 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g140192-nct04186221</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g140192-nct04186221</guid><description><![CDATA[<p>approval_date: Wed, 12 Feb 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04186221?term=NCT04186221&draw=2&rank=1title:</p><p>ide_number: G140192</p><p>nct_number: NCT04186221</p><p>sponsor_name: TransMedics </p><p>study_title: Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation</p>]]></description></item><item><title>G040175-NCT03033043</title><pubDate>Tue, 25 Feb 2020 08:32:12 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g040175-nct03033043</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g040175-nct03033043</guid><description><![CDATA[<p>approval_date: Wed, 19 Feb 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03033043?term=NCT03033043&draw=2&rank=1title:</p><p>ide_number: G040175</p><p>nct_number: NCT03033043</p><p>sponsor_name: Bolton Medical </p><p>study_title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection</p>]]></description></item><item><title>G190013-1-NCT03988166 </title><pubDate>Tue, 25 Feb 2020 08:28:58 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190013-1-nct03988166</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190013-1-nct03988166</guid><description><![CDATA[<p>approval_date: Thu, 06 Feb 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03988166title:</p><p>ide_number: G190013</p><p>nct_number: NCT03988166</p><p>sponsor_name: Vascular Solutions, Inc </p><p>study_title: Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study</p>]]></description></item><item><title>G190217-NCT04131907</title><pubDate>Tue, 11 Feb 2020 08:35:15 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190217-nct04131907</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190217-nct04131907</guid><description><![CDATA[<p>approval_date: Wed, 05 Feb 2020 01:01:01 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04131907title:</p><p>ide_number: G190217</p><p>nct_number: NCT04131907</p><p>sponsor_name: Urotronic Inc. </p><p>study_title: A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH</p>]]></description></item><item><title>G190106-NCT04081727</title><pubDate>Tue, 11 Feb 2020 08:33:56 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190106-nct04081727</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190106-nct04081727</guid><description><![CDATA[<p>approval_date: Wed, 05 Feb 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04081727title:</p><p>ide_number: G190106</p><p>nct_number: NCT04081727</p><p>sponsor_name: ZSX Medical, LLC.</p><p>study_title: Zip-stitch Vaginal Cuff Closure System</p>]]></description></item><item><title>G190087-1-NCT04057352</title><pubDate>Tue, 11 Feb 2020 08:32:22 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190087-1-nct04057352</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190087-1-nct04057352</guid><description><![CDATA[<p>approval_date: Thu, 30 Jan 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04057352title:</p><p>ide_number: G190087</p><p>nct_number: NCT04057352</p><p>sponsor_name: Stryker Neurovascular </p><p>study_title: The Citadel Embolization Device Feasibility Study</p>]]></description></item><item><title>G180179-NCT03952962</title><pubDate>Tue, 11 Feb 2020 08:28:56 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180179-nct03952962</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g180179-nct03952962</guid><description><![CDATA[<p>approval_date: Wed, 29 Jan 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03952962title:</p><p>ide_number: G180179</p><p>nct_number: NCT03952962</p><p>sponsor_name: University of California, Los Angeles </p><p>study_title: Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression</p>]]></description></item><item><title>G190069-NCT04167527 </title><pubDate>Tue, 11 Feb 2020 08:26:52 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190069-nct04167527</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190069-nct04167527</guid><description><![CDATA[<p>approval_date: Thu, 30 Jan 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04167527title:</p><p>ide_number: G190069</p><p>nct_number: NCT04167527</p><p>sponsor_name: Emory University </p><p>study_title: Endovascular Therapy for Low NIHSS Ischemic Strokes</p>]]></description></item><item><title>G190235-NCT04229017 </title><pubDate>Tue, 11 Feb 2020 08:21:27 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190235-nct04229017</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190235-nct04229017</guid><description><![CDATA[<p>approval_date: Thu, 30 Jan 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04229017title:</p><p>ide_number: G190235</p><p>nct_number: NCT04229017</p><p>sponsor_name: Providence Medical Technology, Inc. </p><p>study_title: Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an Adjunct to Posterior Cervical Fusion, When Used in Combination With ACDF in Treatment of Multi-level Cervical Degenerative Disease</p>]]></description></item><item><title>G190147-1-NCT04069156  </title><pubDate>Tue, 28 Jan 2020 08:14:41 -0500</pubDate><link>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190147-1-nct04069156</link><guid>https://www.cms.gov//medicarecoverageideapproved-ide-studies/g190147-1-nct04069156</guid><description><![CDATA[<p>approval_date: Wed, 15 Jan 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04069156title:</p><p>ide_number: G190147-1</p><p>nct_number: NCT04069156</p><p>sponsor_name: Abbott Medical Devices </p><p>study_title: Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study</p>]]></description></item><item><title>G190133-NCT04080778</title><pubDate>Tue, 28 Jan 2020 07:57:47 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190133-nct04080778</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190133-nct04080778</guid><description><![CDATA[<p>approval_date: Wed, 15 Jan 2020 01:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04080778title:</p><p>ide_number: G190133</p><p>nct_number: NCT04080778</p><p>sponsor_name: The University of Texas Health Science Center, Houston</p><p>study_title: Magnetic Seizure Therapy In Bipolar Depression (MST-BpD)</p>]]></description></item><item><title>G180266-NCT04097145</title><pubDate>Tue, 21 Jan 2020 10:11:28 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180266-nct04097145</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180266-nct04097145</guid><description><![CDATA[<p>approval_date: Wed, 30 Oct 2019 01:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT04097145title:</p><p>ide_number: G180266</p><p>nct_number: NCT04097145</p><p>sponsor_name: Edwards Lifesciences </p><p>study_title: A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation</p>]]></description></item><item><title>G190232-NCT04132466</title><pubDate>Mon, 06 Jan 2020 09:13:54 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190232-nct04132466</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190232-nct04132466</guid><description><![CDATA[<p>approval_date: Tue, 31 Dec 2019 01:00:00 -0500</p><p>category: B</p><p>ide_number: G190232</p><p>nct_number: NCT04132466</p><p>sponsor_name: Kestra Medical Technologies, Inc. </p><p>study_title: ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)</p>]]></description></item><item><title>G090207-NCT04087213</title><pubDate>Mon, 06 Jan 2020 09:12:22 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g090207-nct04087213</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g090207-nct04087213</guid><description><![CDATA[<p>approval_date: Thu, 19 Dec 2019 01:00:00 -0500</p><p>category: B</p><p>ide_number: G090207</p><p>nct_number: NCT04087213</p><p>sponsor_name: Deka Research and Development </p><p>study_title: Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis</p>]]></description></item><item><title>G190060-NCT04133168</title><pubDate>Mon, 06 Jan 2020 09:10:40 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190060-nct04133168</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190060-nct04133168</guid><description><![CDATA[<p>approval_date: Tue, 31 Dec 2019 01:00:00 -0500</p><p>category: B</p><p>ide_number: G190060</p><p>nct_number: NCT04133168</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation</p>]]></description></item><item><title>G170152-NCT04153292</title><pubDate>Mon, 06 Jan 2020 09:09:18 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170152-nct04153292</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170152-nct04153292</guid><description><![CDATA[<p>approval_date: Wed, 18 Dec 2019 01:00:00 -0500</p><p>category: B</p><p>ide_number: G170152</p><p>nct_number: NCT04153292</p><p>sponsor_name: Edwards Lifesciences</p><p>study_title: SAPIEN M3 System </p>]]></description></item><item><title>G090151-NCT03901807</title><pubDate>Mon, 06 Jan 2020 09:07:40 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g090151-nct03901807</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g090151-nct03901807</guid><description><![CDATA[<p>approval_date: Fri, 27 Dec 2019 01:00:00 -0500</p><p>category: B</p><p>ide_number: G090151</p><p>nct_number: NCT03901807</p><p>sponsor_name: Spectral Diagnostics (US) Inc.</p><p>study_title: A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock</p>]]></description></item><item><title>G170246-NCT03804060</title><pubDate>Mon, 06 Jan 2020 09:05:29 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170246-nct03804060</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170246-nct03804060</guid><description><![CDATA[<p>approval_date: Wed, 18 Dec 2019 01:00:00 -0500</p><p>category: B</p><p>ide_number: G170246</p><p>nct_number: NCT03804060</p><p>sponsor_name: ZOLL Circulation, Inc., USA </p><p>study_title: A Multicenter, Prospective, Randomized-controlled Trial to Assess the Safety and Feasibility of Cooling as an Adjunctive Therapy to Thrombectomy and Reperfusion in Patients With Acute Cerebral Ischemia and Stroke</p>]]></description></item><item><title>G180234-NCT04003480</title><pubDate>Mon, 06 Jan 2020 09:01:15 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180234-nct04003480</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g180234-nct04003480</guid><description><![CDATA[<p>approval_date: Wed, 18 Dec 2019 01:00:00 -0500</p><p>category: A</p><p>ide_number: G180234</p><p>nct_number: NCT04003480</p><p>sponsor_name: Vascular Graft Solutions Ltd. </p><p>study_title: Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts</p>]]></description></item><item><title>G190058-NCT04129125</title><pubDate>Mon, 06 Jan 2020 08:59:15 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190058-nct04129125</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190058-nct04129125</guid><description><![CDATA[<p>approval_date: Wed, 18 Dec 2019 01:00:00 -0500</p><p>category: B</p><p>ide_number: G190058</p><p>nct_number: NCT04129125</p><p>sponsor_name: Imperative Care, Inc. </p><p>study_title: ZOOM Reperfusion Catheters</p>]]></description></item><item><title>G150242-NCT04065659 </title><pubDate>Mon, 06 Jan 2020 08:54:58 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g150242-nct04065659</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g150242-nct04065659</guid><description><![CDATA[<p>approval_date: Fri, 27 Dec 2019 01:00:00 -0500</p><p>category: B</p><p>ide_number: G150242</p><p>nct_number: NCT04065659</p><p>sponsor_name: NuPulseCV, Inc.</p><p>study_title: NuPulseCV-iVAS</p>]]></description></item><item><title>G190226-NCT04130737</title><pubDate>Mon, 06 Jan 2020 08:52:19 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190226-nct04130737</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190226-nct04130737</guid><description><![CDATA[<p>approval_date: Tue, 17 Dec 2019 13:00:00 -0500</p><p>category: B</p><p>ide_number: G190226</p><p>nct_number: NCT04130737</p><p>sponsor_name: PQ Bypass, Inc. </p><p>study_title: The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2</p>]]></description></item><item><title>G160156-NCT03970538</title><pubDate>Tue, 17 Dec 2019 08:33:41 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g160156-nct03970538</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g160156-nct03970538</guid><description><![CDATA[<p>approval_date: Wed, 04 Dec 2019 00:00:00 -0500</p><p>category: B</p><p>ide_number: G160156</p><p>nct_number: NCT03970538</p><p>sponsor_name: LimFlow, Inc. </p><p>study_title: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial</p>]]></description></item><item><title>G170186-1-NCT03579901 </title><pubDate>Tue, 17 Dec 2019 08:32:06 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170186-1-nct03579901</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g170186-1-nct03579901</guid><description><![CDATA[<p>approval_date: Wed, 04 Dec 2019 00:00:00 -0500</p><p>category: A</p><p>ide_number: G170186</p><p>nct_number: NCT03579901</p><p>sponsor_name: Motiva USA LLC </p><p>study_title: Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk®/SilkSurface® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery</p>]]></description></item><item><title>G190099-1-NCT03994822</title><pubDate>Tue, 17 Dec 2019 08:29:39 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190099-1-nct03994822</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190099-1-nct03994822</guid><description><![CDATA[<p>approval_date: Wed, 04 Dec 2019 00:00:00 -0500</p><p>category: B</p><p>ide_number: G190099</p><p>nct_number: NCT03994822</p><p>sponsor_name: phenox Inc. </p><p>study_title: pRESET for Occlusive Stroke Treatment</p>]]></description></item><item><title>G190186-NCT04060680</title><pubDate>Tue, 17 Dec 2019 08:26:28 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190186-nct04060680</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g190186-nct04060680</guid><description><![CDATA[<p>approval_date: Wed, 04 Dec 2019 00:00:00 -0500</p><p>category: B</p><p>ide_number: G190186</p><p>nct_number: NCT04060680</p><p>sponsor_name: Medtronic Cardiac Rhythm and Heart Failure </p><p>study_title: Extravascular ICD Pivotal Study (EV ICD)</p>]]></description></item><item><title>BB13053-NCT04091672  </title><pubDate>Tue, 17 Dec 2019 08:20:31 -0500</pubDate><link>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/bb13053-nct04091672</link><guid>https://www.cms.gov//httpswwwcmsgovmedicarecoverageideapproved-ide-studies/bb13053-nct04091672</guid><description><![CDATA[<p>approval_date: Wed, 04 Dec 2019 00:00:00 -0500</p><p>category: B</p><p>ide_number: BB13053</p><p>nct_number: NCT04091672</p><p>sponsor_name: Avita Medical </p><p>study_title: A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of the RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction</p>]]></description></item><item><title>Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory</title><pubDate>Wed, 13 Nov 2019 21:24:42 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190011-nct03950492</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190011-nct03950492</guid><description><![CDATA[<p>approval_date: Wed, 30 Oct 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G190011</p><p>nct_number: NCT03950492</p><p>sponsor_name: West Virginia University </p><p>study_title: Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory</p>]]></description></item><item><title>iCLAS™ for Persistent Atrial Fibrillation</title><pubDate>Wed, 13 Nov 2019 21:24:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180263-nct04061603-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180263-nct04061603-</guid><description><![CDATA[<p>approval_date: Wed, 30 Oct 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180263</p><p>nct_number: NCT04061603</p><p>sponsor_name: Adagio Medical </p><p>study_title: iCLAS™ for Persistent Atrial Fibrillation</p>]]></description></item><item><title>A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients</title><pubDate>Wed, 13 Nov 2019 21:24:32 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190020-nct04089059</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190020-nct04089059</guid><description><![CDATA[<p>approval_date: Wed, 30 Oct 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G190020</p><p>nct_number: NCT04089059</p><p>sponsor_name: Endotronix, Inc.</p><p>study_title: A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients</p>]]></description></item><item><title>Alfapump® System in the Treatment of Refractory or Recurrent Ascites: a Multicenter Single Arm Within Subject Crossover Design Pivotal Study (the POSEIDON Study)</title><pubDate>Tue, 05 Nov 2019 02:49:03 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140126-nct03973866</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140126-nct03973866</guid><description><![CDATA[<p>approval_date: Wed, 09 Oct 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G140126</p><p>nct_number: NCT03973866</p><p>sponsor_name: Sequana Medical N.V. </p><p>study_title: Alfapump® System in the Treatment of Refractory or Recurrent Ascites: a Multicenter Single Arm Within Subject Crossover Design Pivotal Study (the POSEIDON Study)</p>]]></description></item><item><title>A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)</title><pubDate>Mon, 04 Nov 2019 02:48:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170126-nct04025008</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170126-nct04025008</guid><description><![CDATA[<p>approval_date: Wed, 02 Oct 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170126</p><p>nct_number: NCT04025008</p><p>sponsor_name: Micro Medical Solution, Inc. </p><p>study_title: A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)</p>]]></description></item><item><title>G180145-NCT04000659</title><pubDate>Mon, 04 Nov 2019 02:48:22 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180145-nct04000659-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180145-nct04000659-</guid><description><![CDATA[<p>approval_date: Fri, 23 Aug 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180145</p><p>nct_number: NCT04000659</p><p>sponsor_name: Episurf Medical Inc.	</p><p>study_title: A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Episealer® Knee System Compared to Microfracture for the Treatment of Focal Femoral Knee Chondral or Osteochondral Lesions</p>]]></description></item><item><title>CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility</title><pubDate>Mon, 04 Nov 2019 02:48:22 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180240-nct02397668-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180240-nct02397668-</guid><description><![CDATA[<p>approval_date: Wed, 04 Sep 2019 12:00:00 -0400</p><p>category: A</p><p>ide_number: G180240</p><p>nct_number: NCT02397668</p><p>sponsor_name: CorMatrix Cardiovascular, Inc.</p><p>study_title: CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility</p>]]></description></item><item><title>A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc C SK and Prodisc C Vivo to Mobi-C Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)</title><pubDate>Mon, 04 Nov 2019 02:48:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190041-nct04012996-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190041-nct04012996-</guid><description><![CDATA[<p>approval_date: Thu, 19 Sep 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G190041</p><p>nct_number: NCT04012996</p><p>sponsor_name: Centinel Spine </p><p>study_title: A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)</p>]]></description></item><item><title>G160197-NCT03947619</title><pubDate>Mon, 04 Nov 2019 02:48:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160197-nct03947619-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160197-nct03947619-</guid><description><![CDATA[<p>approval_date: Wed, 04 Sep 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G160197</p><p>nct_number: NCT03947619</p><p>sponsor_name: Abiomed Inc. </p><p>study_title: Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial	</p>]]></description></item><item><title>G190023-NCT04009512</title><pubDate>Mon, 04 Nov 2019 02:48:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190023-nct04009512-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190023-nct04009512-</guid><description><![CDATA[<p>approval_date: Fri, 23 Aug 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G190023</p><p>nct_number: NCT04009512</p><p>sponsor_name: Matthew Eagleton </p><p>study_title: Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms	</p>]]></description></item><item><title>AtriCure Synergy Ablation System </title><pubDate>Mon, 04 Nov 2019 02:48:17 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170274-2-nct03604432</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170274-2-nct03604432</guid><description><![CDATA[<p>approval_date: Fri, 23 Aug 2019 01:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03604432?term=NCT03604432&rank=1title:</p><p>ide_number: G170274</p><p>nct_number: NCT03604432</p><p>sponsor_name: Spectrum Health </p><p>study_title: AtriCure Synergy Ablation System </p>]]></description></item><item><title>A Multi-center, Randomized, Controlled, Single Blinded, Parallel-group Study Evaluating the Clinical Performance and Safety of LiquiBand FIX8 Versus Control for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair</title><pubDate>Mon, 04 Nov 2019 02:48:14 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190018-nct04009213</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190018-nct04009213</guid><description><![CDATA[<p>approval_date: Wed, 14 Aug 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G190018</p><p>nct_number: NCT04009213</p><p>sponsor_name: Advanced Medical Solutions Ltd.</p><p>study_title: A Multi-center, Randomized, Controlled, Single Blinded, Parallel-group Study Evaluating the Clinical Performance and Safety of LiquiBand FIX8® Versus Control for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair</p>]]></description></item><item><title>Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease</title><pubDate>Mon, 04 Nov 2019 02:48:14 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180057-nct03526991</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180057-nct03526991</guid><description><![CDATA[<p>approval_date: Fri, 23 Aug 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180057</p><p>nct_number: NCT03526991</p><p>sponsor_name: Nora Vanegas-Arroyave </p><p>study_title: Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease</p>]]></description></item><item><title>G180033-1-NCT03523416</title><pubDate>Mon, 04 Nov 2019 02:48:08 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180033-1-nct03523416</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180033-1-nct03523416</guid><description><![CDATA[<p>approval_date: Wed, 31 Jul 2019 12:00:00 -0400</p><p>category: A</p><p>ide_number: G180033</p><p>nct_number: NCT03523416</p><p>sponsor_name: Edwards Lifesciences	</p><p>study_title: Edwards Transcatheter Atrial Shunt System</p>]]></description></item><item><title>Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal</title><pubDate>Mon, 04 Nov 2019 02:48:08 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170118-nct03904147</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170118-nct03904147</guid><description><![CDATA[<p>approval_date: Wed, 24 Jul 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170118</p><p>nct_number: NCT03904147</p><p>sponsor_name: Abbott Medical Devices </p><p>study_title: Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal</p>]]></description></item><item><title>TECNIS Next-Generation OptiBlue Intraocular Lenses (IOLs) Model ZFR00V</title><pubDate>Mon, 04 Nov 2019 02:47:55 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190057-nct03949335</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190057-nct03949335</guid><description><![CDATA[<p>approval_date: Wed, 03 Jul 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G190057</p><p>nct_number: NCT03949335</p><p>sponsor_name: Johnson &#x26; Johnson Surgical Vision, Inc.</p><p>study_title: TECNIS Next-Generation OptiBlue Intraocular Lenses (IOLs) Model ZFR00V</p>]]></description></item><item><title>Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)</title><pubDate>Mon, 04 Nov 2019 02:47:53 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180272-nct03831048-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180272-nct03831048-</guid><description><![CDATA[<p>approval_date: Fri, 24 May 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180272</p><p>nct_number: NCT03831048</p><p>sponsor_name: TransMedics</p><p>study_title: Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)</p>]]></description></item><item><title>Tailoring Maintenance Therapy to CD5+ Regulatory B Cell Recovery in ANCA Vasculitis</title><pubDate>Mon, 04 Nov 2019 02:47:51 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180297-nct03906227</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180297-nct03906227</guid><description><![CDATA[<p>approval_date: Fri, 17 May 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180297</p><p>nct_number: NCT03906227</p><p>sponsor_name: University of North Carolina, Chapel Hill </p><p>study_title: Tailoring Maintenance Therapy to CD5+ Regulatory B Cell Recovery in ANCA Vasculitis</p>]]></description></item><item><title>The TELSA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke</title><pubDate>Mon, 04 Nov 2019 02:47:46 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190006-nct03805308-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g190006-nct03805308-</guid><description><![CDATA[<p>approval_date: Fri, 17 May 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G190006</p><p>nct_number: NCT03805308</p><p>sponsor_name: Mercy Health Ohio</p><p>study_title: The TELSA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke</p>]]></description></item><item><title>G170109-1-NCT03200704</title><pubDate>Mon, 04 Nov 2019 02:47:46 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170109-1-nct03200704-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170109-1-nct03200704-</guid><description><![CDATA[<p>approval_date: Fri, 17 May 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170109</p><p>nct_number: NCT03200704</p><p>sponsor_name: Novadaq Technologies ULC, now a part of Stryker </p><p>study_title: Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer</p>]]></description></item><item><title>Interscope Endorotor Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus</title><pubDate>Mon, 04 Nov 2019 02:47:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170106-nct03364114-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170106-nct03364114-</guid><description><![CDATA[<p>approval_date: Fri, 17 May 2019 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03364114title:</p><p>ide_number: G170106</p><p>nct_number: NCT03364114</p><p>sponsor_name: Interscope, Inc. </p><p>study_title: Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus</p>]]></description></item><item><title>Phasix Mesh</title><pubDate>Mon, 04 Nov 2019 02:47:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180186-nct03911700</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180186-nct03911700</guid><description><![CDATA[<p>approval_date: Fri, 24 May 2019 12:00:00 -0400</p><p>category: A</p><p>ide_number: G180186</p><p>nct_number: NCT03911700</p><p>sponsor_name: Davol, Inc.</p><p>study_title: Phasix Mesh</p>]]></description></item><item><title>A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma</title><pubDate>Mon, 04 Nov 2019 02:47:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180278-nct03899636</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180278-nct03899636</guid><description><![CDATA[<p>approval_date: Fri, 03 May 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180278</p><p>nct_number: NCT03899636</p><p>sponsor_name: Angiodynamics, Inc. </p><p>study_title: A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife® System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma</p>]]></description></item><item><title>A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation</title><pubDate>Mon, 04 Nov 2019 02:47:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180237-nct03783884</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180237-nct03783884</guid><description><![CDATA[<p>approval_date: Thu, 09 May 2019 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03783884title:</p><p>ide_number: G180237</p><p>nct_number: NCT03783884</p><p>sponsor_name: Lungpacer Medical Inc. </p><p>study_title: A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation</p>]]></description></item><item><title>G160184-NCT03262909</title><pubDate>Mon, 04 Nov 2019 02:47:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160184-nct03262909</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160184-nct03262909</guid><description><![CDATA[<p>approval_date: Fri, 26 Apr 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G160184</p><p>nct_number: NCT03262909</p><p>sponsor_name: Regentis Biomaterials </p><p>study_title: A Prospective, Open-Label, Multicenter Pivotal Study to Evaluate the Safety and Efficacy of GelrinC® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle: A Comparison to Historical Control Microfracture	</p>]]></description></item><item><title>SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke</title><pubDate>Mon, 04 Nov 2019 02:47:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180275-nct03876457-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180275-nct03876457-</guid><description><![CDATA[<p>approval_date: Thu, 25 Apr 2019 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03876457title:</p><p>ide_number: G180275</p><p>nct_number: NCT03876457</p><p>sponsor_name: The University of Texas Health Science Center, Houston</p><p>study_title: SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke</p>]]></description></item><item><title>G180208-NCT03588286</title><pubDate>Mon, 04 Nov 2019 02:47:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180208-nct03588286</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180208-nct03588286</guid><description><![CDATA[<p>approval_date: Thu, 25 Apr 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180208</p><p>nct_number: NCT03588286</p><p>sponsor_name: Western Sydney Local Health District </p><p>study_title: Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)	</p>]]></description></item><item><title>Evaluation of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms</title><pubDate>Mon, 04 Nov 2019 02:47:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150071-nct03728985</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150071-nct03728985</guid><description><![CDATA[<p>approval_date: Thu, 25 Apr 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G150071</p><p>nct_number: NCT03728985</p><p>sponsor_name: W.L.Gore &#x26; Associates</p><p>study_title: Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms</p>]]></description></item><item><title>XIENCE 28 USA Study</title><pubDate>Mon, 04 Nov 2019 02:47:27 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170081-nct03815175-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170081-nct03815175-</guid><description><![CDATA[<p>approval_date: Mon, 01 Apr 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170081</p><p>nct_number: NCT03815175</p><p>sponsor_name: Abbott Medical Devices</p><p>study_title: XIENCE 28 USA Study</p>]]></description></item><item><title>Cochlear Implantation During Vestibular Schwannoma Removal or During Labyrinthectomy Surgery for Treatment of Meniere's Disease</title><pubDate>Mon, 04 Nov 2019 02:47:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170139-nct03795675</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170139-nct03795675</guid><description><![CDATA[<p>approval_date: Fri, 15 Mar 2019 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170139</p><p>nct_number: NCT03795675</p><p>sponsor_name: Ohio State University</p><p>study_title: Cochlear Implantation During Vestibular Schwannoma Removal or During Labyrinthectomy Surgery for Treatment of Meniere's Disease</p>]]></description></item><item><title>G030132-NCT03484455</title><pubDate>Mon, 04 Nov 2019 02:47:21 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g030132-nct03484455</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g030132-nct03484455</guid><description><![CDATA[<p>approval_date: Fri, 22 Feb 2019 12:00:00 -0500</p><p>category: B</p><p>ide_number: G030132</p><p>nct_number: NCT03484455</p><p>sponsor_name: Organ Recovery Systems </p><p>study_title: LifePort® Liver Transporter System and Vasosol® Machine Perfusion Solution	</p>]]></description></item><item><title>The Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as an Adjunct to Advanced Cardiac Life Support in Non-traumatic Cardiac Arrest: an Early Feasibility Trial</title><pubDate>Mon, 04 Nov 2019 02:47:21 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170307-nct03703453-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170307-nct03703453-</guid><description><![CDATA[<p>approval_date: Thu, 28 Feb 2019 12:00:00 -0500</p><p>category: A</p><p>ide_number: G170307</p><p>nct_number: NCT03703453</p><p>sponsor_name: Yale University </p><p>study_title: The Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as an Adjunct to Advanced Cardiac Life Support in Non-traumatic Cardiac Arrest: an Early Feasibility Trial</p>]]></description></item><item><title>OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study</title><pubDate>Mon, 04 Nov 2019 02:47:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160227-1-nct03716102</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160227-1-nct03716102</guid><description><![CDATA[<p>approval_date: Fri, 15 Feb 2019 12:00:00 -0500</p><p>category: B</p><p>ide_number: G160227</p><p>nct_number: NCT03716102</p><p>sponsor_name: Svelte Medical Systems, Inc. </p><p>study_title: OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study</p>]]></description></item><item><title>Evaluation of the QDOT MICRO Catheter for pulmonary vein isolation in subjects with Paroxysmal Atrial Fibrillation </title><pubDate>Mon, 04 Nov 2019 02:47:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180176-nct03775512-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180176-nct03775512-</guid><description><![CDATA[<p>approval_date: Fri, 22 Feb 2019 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180176</p><p>nct_number: NCT03775512</p><p>sponsor_name: Biosense Webster, Inc.</p><p>study_title: Evaluation of the QDOT MICRO™ Catheter for pulmonary vein isolation in subjects with Paroxysmal Atrial Fibrillation </p>]]></description></item><item><title>AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery</title><pubDate>Mon, 04 Nov 2019 02:47:16 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180173-1-nct03732794-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180173-1-nct03732794-</guid><description><![CDATA[<p>approval_date: Fri, 15 Feb 2019 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03732794title:</p><p>ide_number: G180173</p><p>nct_number: NCT03732794</p><p>sponsor_name: AtriCure, Inc. </p><p>study_title: AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery</p>]]></description></item><item><title>G180175-NCT03693807</title><pubDate>Mon, 04 Nov 2019 02:47:14 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180175-nct03693807</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180175-nct03693807</guid><description><![CDATA[<p>approval_date: Fri, 08 Feb 2019 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180175</p><p>nct_number: NCT03693807</p><p>sponsor_name: Memorial Sloan Kettering Cancer Center </p><p>study_title: A Pilot Protocol Evaluating Safety of Using the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Colorectal Carcinoma or Cholangiocarcinoma	</p>]]></description></item><item><title>Randomized, Controlled, Single-blind Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care</title><pubDate>Mon, 04 Nov 2019 02:47:11 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g110119-nct03762655</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g110119-nct03762655</guid><description><![CDATA[<p>approval_date: Fri, 01 Feb 2019 12:00:00 -0500</p><p>category: A</p><p>ide_number: G110119</p><p>nct_number: NCT03762655</p><p>sponsor_name: InVivo Therapeutics</p><p>study_title: Randomized, Controlled, Single-blind Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care</p>]]></description></item><item><title>G170190-NCT03767881</title><pubDate>Mon, 04 Nov 2019 02:47:10 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170190-nct03767881</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170190-nct03767881</guid><description><![CDATA[<p>approval_date: Fri, 25 Jan 2019 12:00:00 -0500</p><p>category: B</p><p>ide_number: G170190</p><p>nct_number: NCT03767881</p><p>sponsor_name: Boston Scientific Corporation </p><p>study_title: A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage	</p>]]></description></item><item><title>CLASP TR EFS</title><pubDate>Mon, 04 Nov 2019 02:47:10 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180266-nct03745313</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180266-nct03745313</guid><description><![CDATA[<p>approval_date: Fri, 01 Feb 2019 12:00:00 -0500</p><p>category: A</p><p>ide_number: G180266</p><p>nct_number: NCT03745313</p><p>sponsor_name: Edwards Lifesciences</p><p>study_title: CLASP TR EFS</p>]]></description></item><item><title>G180143-NCT03756558</title><pubDate>Mon, 04 Nov 2019 02:47:10 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180143-nct03756558-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180143-nct03756558-</guid><description><![CDATA[<p>approval_date: Fri, 25 Jan 2019 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180143</p><p>nct_number: NCT03756558</p><p>sponsor_name: Terumo Medical Corporation </p><p>study_title: Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System	</p>]]></description></item><item><title>G180168-NCT03763747</title><pubDate>Mon, 04 Nov 2019 02:47:10 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180168-nct03763747-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180168-nct03763747-</guid><description><![CDATA[<p>approval_date: Fri, 25 Jan 2019 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180168</p><p>nct_number: NCT03763747</p><p>sponsor_name: OrbusNeich</p><p>study_title: Scoreflex NC - Scoring PTCA Catheter: A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Safety and Device Procedural Success of the Scoreflex NC Scoring PTCA Catheter in Subjects With Stenotic Coronary Arteries During Percutaneous Coronary Intervention.</p>]]></description></item><item><title>Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)</title><pubDate>Mon, 04 Nov 2019 02:47:00 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180139-1-nct03683030</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180139-1-nct03683030</guid><description><![CDATA[<p>approval_date: Thu, 10 Jan 2019 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180139-1</p><p>nct_number: NCT03683030</p><p>sponsor_name: Biosense Webster, Inc. </p><p>study_title: Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)</p>]]></description></item><item><title>Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries</title><pubDate>Mon, 04 Nov 2019 02:46:57 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180146-nct03595176</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180146-nct03595176</guid><description><![CDATA[<p>approval_date: Thu, 13 Dec 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180146</p><p>nct_number: NCT03595176</p><p>sponsor_name: Shockwave Medical, Inc. </p><p>study_title: Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries</p>]]></description></item><item><title>Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens</title><pubDate>Mon, 04 Nov 2019 02:46:55 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180075-nct03633695</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180075-nct03633695</guid><description><![CDATA[<p>approval_date: Thu, 13 Dec 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180075</p><p>nct_number: NCT03633695</p><p>sponsor_name: AcuFocus, Inc. </p><p>study_title: Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens</p>]]></description></item><item><title>Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis</title><pubDate>Mon, 04 Nov 2019 02:46:54 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180127-nct03694210</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180127-nct03694210</guid><description><![CDATA[<p>approval_date: Fri, 30 Nov 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180127</p><p>nct_number: NCT03694210</p><p>sponsor_name: Interscope, Inc. </p><p>study_title: Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis</p>]]></description></item><item><title>G170063-NCT03353688</title><pubDate>Mon, 04 Nov 2019 02:46:51 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170063-nct03353688-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170063-nct03353688-</guid><description><![CDATA[<p>approval_date: Fri, 30 Nov 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G170063</p><p>nct_number: NCT03353688</p><p>sponsor_name: University of Alabama at Birmingham </p><p>study_title: Noninvasive Biomarkers to Advance Emerging DBS Electrode Technologies in Parkinson's Disease	</p>]]></description></item><item><title>Evaluation of the Cardio Flow FreedomFlow Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease</title><pubDate>Mon, 04 Nov 2019 02:46:49 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170219-nct03635190</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170219-nct03635190</guid><description><![CDATA[<p>approval_date: Fri, 30 Nov 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G170219</p><p>nct_number: NCT03635190</p><p>sponsor_name: Cardio Flow, Inc. </p><p>study_title: Evaluation of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease</p>]]></description></item><item><title>BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction</title><pubDate>Mon, 04 Nov 2019 02:46:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180155-nct02341534-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180155-nct02341534-</guid><description><![CDATA[<p>approval_date: Fri, 16 Nov 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180155</p><p>nct_number: NCT02341534</p><p>sponsor_name: Biotronik SE &#x26; Co. KG </p><p>study_title: BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction</p>]]></description></item><item><title>SYNergy Stent System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month</title><pubDate>Mon, 04 Nov 2019 02:46:43 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180024-nct03606642</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180024-nct03606642</guid><description><![CDATA[<p>approval_date: Fri, 16 Nov 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G180024</p><p>nct_number: NCT03606642</p><p>sponsor_name: HonorHealth Research Institute </p><p>study_title: SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month</p>]]></description></item><item><title>A Post-approval Study of the Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System</title><pubDate>Mon, 04 Nov 2019 02:46:42 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140178-nct03584464</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140178-nct03584464</guid><description><![CDATA[<p>approval_date: Fri, 16 Nov 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G140178</p><p>nct_number: NCT03584464</p><p>sponsor_name: Medtronic Vascular</p><p>study_title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System</p>]]></description></item><item><title>G140195-NCT03686215</title><pubDate>Mon, 04 Nov 2019 02:46:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140195-nct03686215</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140195-nct03686215</guid><description><![CDATA[<p>approval_date: Fri, 09 Nov 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G140195</p><p>nct_number: NCT03686215</p><p>sponsor_name: Lumicell, Inc. </p><p>study_title: Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer</p>]]></description></item><item><title>G170312-NCT03641677</title><pubDate>Mon, 04 Nov 2019 02:46:40 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170312-nct03641677-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170312-nct03641677-</guid><description><![CDATA[<p>approval_date: Fri, 09 Nov 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G170312</p><p>nct_number: NCT03641677</p><p>sponsor_name: Lung Bioengineering Inc. </p><p>study_title: Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility	</p>]]></description></item><item><title>The "RADIANCE II" Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension</title><pubDate>Mon, 04 Nov 2019 02:46:34 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150144-nct03614260</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150144-nct03614260</guid><description><![CDATA[<p>approval_date: Fri, 26 Oct 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G150144</p><p>nct_number: NCT03614260</p><p>sponsor_name: ReCor Medical, Inc. </p><p>study_title: The "RADIANCE II" Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension</p>]]></description></item><item><title>G170283-1-NCT03546374</title><pubDate>Mon, 04 Nov 2019 02:46:34 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170283-1-nct03546374</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170283-1-nct03546374</guid><description><![CDATA[<p>approval_date: Thu, 01 Nov 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170283-1 </p><p>nct_number: NCT03546374</p><p>sponsor_name: Medtronic Cardiovascular </p><p>study_title: Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)	</p>]]></description></item><item><title>G160277-NCT03412643</title><pubDate>Mon, 04 Nov 2019 02:46:32 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160277-nct03412643</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160277-nct03412643</guid><description><![CDATA[<p>approval_date: Fri, 26 Oct 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G160277</p><p>nct_number: NCT03412643</p><p>sponsor_name: Celcuity  </p><p>study_title: An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected with a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)</p>]]></description></item><item><title>A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease</title><pubDate>Mon, 04 Nov 2019 02:46:31 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180188-nct03645681-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180188-nct03645681-</guid><description><![CDATA[<p>approval_date: Fri, 28 Sep 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180188</p><p>nct_number: NCT03645681</p><p>sponsor_name: InnAVasc Medical, Inc. </p><p>study_title: A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease</p>]]></description></item><item><title>Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN)</title><pubDate>Mon, 04 Nov 2019 02:46:30 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180034-nct03621319</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180034-nct03621319</guid><description><![CDATA[<p>approval_date: Fri, 19 Oct 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180034</p><p>nct_number: NCT03621319</p><p>sponsor_name: Erbe Elektromedizin GmbH </p><p>study_title: Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN)</p>]]></description></item><item><title>A Prospective Clinical Evaluation of the DiamondTemp System for the Treatment of Persistent Atrial Fibrillation</title><pubDate>Mon, 04 Nov 2019 02:46:28 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180153-nct03643224</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180153-nct03643224</guid><description><![CDATA[<p>approval_date: Fri, 05 Oct 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180153</p><p>nct_number: NCT03643224</p><p>sponsor_name: EPIX Therapeutics </p><p>study_title: A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation</p>]]></description></item><item><title>ADvance II: A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer's Disease</title><pubDate>Mon, 04 Nov 2019 02:46:28 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g110220-nct03622905</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g110220-nct03622905</guid><description><![CDATA[<p>approval_date: Fri, 12 Oct 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G110220</p><p>nct_number: NCT03622905</p><p>sponsor_name: Functional Neuromodulation Ltd </p><p>study_title: ADvance II: A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer's Disease</p>]]></description></item><item><title>CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD</title><pubDate>Mon, 04 Nov 2019 02:46:28 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130013-nct03179800</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130013-nct03179800</guid><description><![CDATA[<p>approval_date: Fri, 21 Sep 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G130013</p><p>nct_number: NCT03179800</p><p>sponsor_name: Vascular Dynamics, Inc. </p><p>study_title: CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™</p>]]></description></item><item><title>CRYSTAL Study: A Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.</title><pubDate>Mon, 04 Nov 2019 02:46:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170030-nct03423511</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170030-nct03423511</guid><description><![CDATA[<p>approval_date: Fri, 12 Oct 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170030</p><p>nct_number: NCT03423511</p><p>sponsor_name: Micell Technologies </p><p>study_title: CRYSTAL Study: A Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.</p>]]></description></item><item><title>Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair of Ascending Aortic Pathologies</title><pubDate>Mon, 04 Nov 2019 02:46:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170196-nct03322033</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170196-nct03322033</guid><description><![CDATA[<p>approval_date: Fri, 12 Oct 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170196</p><p>nct_number: NCT03322033</p><p>sponsor_name: Baylor Research Institute </p><p>study_title: Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair of Ascending Aortic Pathologies</p>]]></description></item><item><title>Safety and Effectiveness of TactiCath Contact Force, Sensor Enabled (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)</title><pubDate>Mon, 04 Nov 2019 02:46:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180149-nct03650556</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180149-nct03650556</guid><description><![CDATA[<p>approval_date: Fri, 12 Oct 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180149</p><p>nct_number: NCT03650556</p><p>sponsor_name: St. Jude Medical </p><p>study_title: Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)</p>]]></description></item><item><title>G130203-NCT02221934</title><pubDate>Mon, 04 Nov 2019 02:46:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130203-nct02221934</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130203-nct02221934</guid><description><![CDATA[<p>approval_date: Fri, 12 Oct 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G130203</p><p>nct_number: NCT02221934</p><p>sponsor_name: Neuros Medical, Inc. </p><p>study_title: High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study	</p>]]></description></item><item><title>A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures</title><pubDate>Mon, 04 Nov 2019 02:46:25 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb13803-nct03459287</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb13803-nct03459287</guid><description><![CDATA[<p>approval_date: Fri, 05 Oct 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: BB13803</p><p>nct_number: NCT03459287</p><p>sponsor_name: Cerus Corporation</p><p>study_title: A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures</p>]]></description></item><item><title>Onyx ONE Clear: A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)</title><pubDate>Mon, 04 Nov 2019 02:46:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140178-nct03647475</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140178-nct03647475</guid><description><![CDATA[<p>approval_date: Fri, 28 Sep 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G140178</p><p>nct_number: NCT03647475</p><p>sponsor_name: Medtronic Vascular </p><p>study_title: Onyx ONE Clear: A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)</p>]]></description></item><item><title>TriCinch Coil System</title><pubDate>Mon, 04 Nov 2019 02:46:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180151-nct03632967</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180151-nct03632967</guid><description><![CDATA[<p>approval_date: Fri, 28 Sep 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: G180151</p><p>nct_number: NCT03632967</p><p>sponsor_name: 4Tech Cardio Ireland Limited</p><p>study_title: TriCinch Coil System</p>]]></description></item><item><title>An Early Feasibility Evaluation of the AccuCinch Ventricular Repair System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study</title><pubDate>Mon, 04 Nov 2019 02:46:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150249-nct03533517</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150249-nct03533517</guid><description><![CDATA[<p>approval_date: Thu, 13 Sep 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: G150249</p><p>nct_number: NCT03533517</p><p>sponsor_name: Ancora Heart, Inc.</p><p>study_title: An Early Feasibility Evaluation of the AccuCinch® Ventricular Repair System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study</p>]]></description></item><item><title>An Early Feasibility Study of the AccuCinch Ventricular Repair System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study</title><pubDate>Mon, 04 Nov 2019 02:46:17 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150249-nct03560167-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150249-nct03560167-</guid><description><![CDATA[<p>approval_date: Thu, 13 Sep 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: G150249</p><p>nct_number: NCT03560167</p><p>sponsor_name: Ancora Heart, Inc. </p><p>study_title: An Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study</p>]]></description></item><item><title>ArcticLine Feasibility Study</title><pubDate>Mon, 04 Nov 2019 02:46:17 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170182-nct03604263</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170182-nct03604263</guid><description><![CDATA[<p>approval_date: Thu, 13 Sep 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: G170182</p><p>nct_number: NCT03604263</p><p>sponsor_name: Medtronic Atrial Fibrillation Solutions </p><p>study_title: ArcticLine Feasibility Study</p>]]></description></item><item><title>Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension</title><pubDate>Mon, 04 Nov 2019 02:46:13 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180008-nct03556085</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180008-nct03556085</guid><description><![CDATA[<p>approval_date: Thu, 23 Aug 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180008</p><p>nct_number: NCT03556085</p><p>sponsor_name: Serenity Medical, Inc. </p><p>study_title: Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension</p>]]></description></item><item><title>G170144-NCT03573206</title><pubDate>Mon, 04 Nov 2019 02:46:08 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170144-nct03573206-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170144-nct03573206-</guid><description><![CDATA[<p>approval_date: Wed, 15 Aug 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170144</p><p>nct_number: NCT03573206</p><p>sponsor_name: Cardiva Medical, Inc.</p><p>study_title: Multi-center, Single Arm Continuing Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) for the Management of the Femoral Venotomy After Catheter-based Interventions Performed Via 6-12 Fr Procedural Sheaths With Single or Multiple Access Sites Per Limb</p>]]></description></item><item><title>Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries - ILLUMENATE BTK</title><pubDate>Mon, 04 Nov 2019 02:46:08 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160220-nct03175744-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160220-nct03175744-</guid><description><![CDATA[<p>approval_date: Tue, 07 Aug 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G160220</p><p>nct_number: NCT03175744</p><p>sponsor_name: Spectranetics Corporation </p><p>study_title: Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries - ILLUMENATE BTK</p>]]></description></item><item><title>RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure</title><pubDate>Mon, 04 Nov 2019 02:46:08 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180020-nct03499236</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180020-nct03499236</guid><description><![CDATA[<p>approval_date: Wed, 15 Aug 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180020</p><p>nct_number: NCT03499236</p><p>sponsor_name: V-Wave Ltd </p><p>study_title: RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure</p>]]></description></item><item><title>An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo in End-Stage Renal Disease Subjects</title><pubDate>Mon, 04 Nov 2019 02:46:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180016-nct03536663</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180016-nct03536663</guid><description><![CDATA[<p>approval_date: Tue, 24 Jul 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: G180016</p><p>nct_number: NCT03536663</p><p>sponsor_name: Fresenius Medical Care North America</p><p>study_title: An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects</p>]]></description></item><item><title>Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification</title><pubDate>Mon, 04 Nov 2019 02:46:03 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140240-nct03539458</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140240-nct03539458</guid><description><![CDATA[<p>approval_date: Fri, 03 Aug 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G140240</p><p>nct_number: NCT03539458</p><p>sponsor_name: Tendyne Holdings, Inc. </p><p>study_title: Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification</p>]]></description></item><item><title>G090174-NCT03364660</title><pubDate>Mon, 04 Nov 2019 02:46:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g090174-nct03364660</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g090174-nct03364660</guid><description><![CDATA[<p>approval_date: Fri, 20 Jul 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G090174</p><p>nct_number: NCT03364660</p><p>sponsor_name: University of Louisville	                                                                                                                                                                                                                                      </p><p>study_title: Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury</p>]]></description></item><item><title>A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia</title><pubDate>Mon, 04 Nov 2019 02:45:57 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180073-nct03551496</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180073-nct03551496</guid><description><![CDATA[<p>approval_date: Fri, 13 Jul 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180073</p><p>nct_number: NCT03551496</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia</p>]]></description></item><item><title>PHIL dAVF: Study of PHIL Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas</title><pubDate>Mon, 04 Nov 2019 02:45:55 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170203-nct03467542</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170203-nct03467542</guid><description><![CDATA[<p>approval_date: Wed, 27 Jun 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170203</p><p>nct_number: NCT03467542</p><p>sponsor_name: Microvention-Terumo, Inc.</p><p>study_title: PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas</p>]]></description></item><item><title>ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial</title><pubDate>Mon, 04 Nov 2019 02:45:52 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180041-nct03499964</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180041-nct03499964</guid><description><![CDATA[<p>approval_date: Thu, 21 Jun 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180041</p><p>nct_number: NCT03499964</p><p>sponsor_name: Urotronic Inc.</p><p>study_title: ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial</p>]]></description></item><item><title>OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI</title><pubDate>Mon, 04 Nov 2019 02:45:52 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180052-nct03507777</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180052-nct03507777</guid><description><![CDATA[<p>approval_date: Thu, 21 Jun 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180052</p><p>nct_number: NCT03507777</p><p>sponsor_name: St. Jude Medical </p><p>study_title: OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI</p>]]></description></item><item><title>Next-Generation TECNIS Symfony Extended Range of Vision IOL </title><pubDate>Mon, 04 Nov 2019 02:45:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180044-nct03500198</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180044-nct03500198</guid><description><![CDATA[<p>approval_date: Thu, 21 Jun 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180044</p><p>nct_number: NCT03500198</p><p>sponsor_name: Johnson &#x26; Johnson Surgical Vision, Inc.</p><p>study_title: Next-Generation TECNIS Symfony Extended Range of Vision IOL </p>]]></description></item><item><title>The Mount Sinai Diabetic Foot Ulcer Prospective Trial</title><pubDate>Mon, 04 Nov 2019 02:45:49 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170254-nct03404895</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170254-nct03404895</guid><description><![CDATA[<p>approval_date: Fri, 15 Jun 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170254</p><p>nct_number: NCT03404895</p><p>sponsor_name: Windsor Ting</p><p>study_title: The Mount Sinai Diabetic Foot Ulcer Prospective Trial</p>]]></description></item><item><title>LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study</title><pubDate>Mon, 04 Nov 2019 02:45:49 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170232-1-nct03372096</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170232-1-nct03372096</guid><description><![CDATA[<p>approval_date: Fri, 15 Jun 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170232</p><p>nct_number: NCT03372096</p><p>sponsor_name: University of North Carolina, Chapel Hill </p><p>study_title: LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study</p>]]></description></item><item><title>BB14861-NCT03518333</title><pubDate>Mon, 04 Nov 2019 02:45:46 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb14861-nct03518333</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb14861-nct03518333</guid><description><![CDATA[<p>approval_date: Fri, 15 Jun 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: BB14861</p><p>nct_number: NCT03518333</p><p>sponsor_name: Tissue Genesis, LLC	</p><p>study_title: Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction</p>]]></description></item><item><title>A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents</title><pubDate>Mon, 04 Nov 2019 02:45:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170261-nct03525808-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170261-nct03525808-</guid><description><![CDATA[<p>approval_date: Fri, 08 Jun 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170261</p><p>nct_number: NCT03525808</p><p>sponsor_name: Boston Scientific Corporation </p><p>study_title: A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents</p>]]></description></item><item><title>G170251-NCT03403426</title><pubDate>Mon, 04 Nov 2019 02:45:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170251-nct03403426</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170251-nct03403426</guid><description><![CDATA[<p>approval_date: Tue, 13 Mar 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170251</p><p>nct_number: NCT03403426</p><p>sponsor_name: ReFlow Medical, Inc.</p><p>study_title: A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries	</p>]]></description></item><item><title>Tendyne Mitral Valve System </title><pubDate>Mon, 04 Nov 2019 02:45:36 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140240-nct03433274-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140240-nct03433274-</guid><description><![CDATA[<p>approval_date: Tue, 08 May 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G140240</p><p>nct_number: NCT03433274</p><p>sponsor_name: Abbott</p><p>study_title: Tendyne Mitral Valve System </p>]]></description></item><item><title>A 2x2 Factorial Randomized Controlled Trial of Colchicine and Spironolactone in Patients With ST-elevation Myocardial Infarction (STEMI) / SYNERGY Stent Registry - CLEAR-SYNERGY (OASIS-9)</title><pubDate>Mon, 04 Nov 2019 02:45:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170179-nct03048825</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170179-nct03048825</guid><description><![CDATA[<p>approval_date: Wed, 23 May 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170179</p><p>nct_number: NCT03048825</p><p>sponsor_name: Population Health Research Institute </p><p>study_title: A 2x2 Factorial Randomized Controlled Trial of Colchicine and Spironolactone in Patients With ST-elevation Myocardial Infarction (STEMI) / SYNERGY Stent Registry - CLEAR-SYNERGY (OASIS-9)</p>]]></description></item><item><title>FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study</title><pubDate>Mon, 04 Nov 2019 02:45:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170221-nct03490201-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170221-nct03490201-</guid><description><![CDATA[<p>approval_date: Wed, 23 May 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170221</p><p>nct_number: NCT03490201</p><p>sponsor_name: St. Jude Medical </p><p>study_title: FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study</p>]]></description></item><item><title>G170266-NCT03451786</title><pubDate>Mon, 04 Nov 2019 02:45:30 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170266-nct03451786</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170266-nct03451786</guid><description><![CDATA[<p>approval_date: Mon, 21 May 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: G170266</p><p>nct_number: NCT03451786</p><p>sponsor_name: Carl Zeiss Medictec Production, LLC</p><p>study_title: A Multi-Center, Prospective Clinical Trial To Evaluate The Safety And Effectiveness of the CT LUCIA 611p Posterior Chamber Intraocular Lens For Correction of Aphakia Following Cataract Removal	</p>]]></description></item><item><title>A Validation of the Assisted Fluid Management Feature</title><pubDate>Mon, 04 Nov 2019 02:45:30 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170204-nct03469570-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170204-nct03469570-</guid><description><![CDATA[<p>approval_date: Tue, 22 May 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: G170204</p><p>nct_number: NCT03469570</p><p>sponsor_name: Edwards Lifesciences </p><p>study_title: A Validation of the Assisted Fluid Management Feature</p>]]></description></item><item><title>EVOLVE 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)</title><pubDate>Mon, 04 Nov 2019 02:45:27 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170282-1-nct03350542-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170282-1-nct03350542-</guid><description><![CDATA[<p>approval_date: Mon, 07 May 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170282</p><p>nct_number: NCT03350542</p><p>sponsor_name: Boston Scientific Corporation </p><p>study_title: EVOLVE 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)</p>]]></description></item><item><title>G150222-NCT02654015</title><pubDate>Mon, 04 Nov 2019 02:45:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150222-nct02654015</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150222-nct02654015</guid><description><![CDATA[<p>approval_date: Fri, 27 Apr 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G150222</p><p>nct_number: NCT02654015</p><p>sponsor_name: J. Mocco </p><p>study_title: INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)	</p>]]></description></item><item><title>BB17234-NCT03435172</title><pubDate>Mon, 04 Nov 2019 02:45:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17234-nct03435172</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17234-nct03435172</guid><description><![CDATA[<p>approval_date: Fri, 27 Apr 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: BB17234</p><p>nct_number: NCT03435172</p><p>sponsor_name: Cytori Therapeutics </p><p>study_title: Safety and Feasibility of Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Deep Partial Thickness and Full Thickness Thermal Wounds (RELIEF)	</p>]]></description></item><item><title>Treatment With Intent to Generate Endovascular Reperfusion</title><pubDate>Mon, 04 Nov 2019 02:45:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180004-nct03474549-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g180004-nct03474549-</guid><description><![CDATA[<p>approval_date: Tue, 01 May 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G180004</p><p>nct_number: NCT03474549</p><p>sponsor_name: Rapid Medical</p><p>study_title: Treatment With Intent to Generate Endovascular Reperfusion</p>]]></description></item><item><title>INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry </title><pubDate>Mon, 04 Nov 2019 02:45:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150222-1-nct02661672-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150222-1-nct02661672-</guid><description><![CDATA[<p>approval_date: Fri, 27 Apr 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G150222-1</p><p>nct_number: NCT02661672</p><p>sponsor_name: J. Mocco </p><p>study_title: INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry </p>]]></description></item><item><title>Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)</title><pubDate>Mon, 04 Nov 2019 02:45:22 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17905%253fnct03455725</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17905%253fnct03455725</guid><description><![CDATA[<p>approval_date: Wed, 02 May 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: BB17905</p><p>nct_number: NCT03455725</p><p>sponsor_name: BioCardia, Inc. </p><p>study_title: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)</p>]]></description></item><item><title>MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage</title><pubDate>Mon, 04 Nov 2019 02:45:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170129-nct03342664</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170129-nct03342664</guid><description><![CDATA[<p>approval_date: Fri, 27 Apr 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170129</p><p>nct_number: NCT03342664</p><p>sponsor_name: Penumbra Inc. </p><p>study_title: MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage</p>]]></description></item><item><title>Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults</title><pubDate>Mon, 04 Nov 2019 02:45:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160256-nct03007472-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160256-nct03007472-</guid><description><![CDATA[<p>approval_date: Fri, 05 May 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03007472?term=NCT03007472&rank=1title:</p><p>ide_number: G160256</p><p>nct_number: NCT03007472</p><p>sponsor_name: Cochlear</p><p>study_title: Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults</p>]]></description></item><item><title>P-15L Bone Graft </title><pubDate>Mon, 04 Nov 2019 02:45:14 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170300-nct03438747</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170300-nct03438747</guid><description><![CDATA[<p>approval_date: Thu, 12 Apr 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170300</p><p>nct_number: NCT03438747</p><p>sponsor_name: Cerapedics, Inc.</p><p>study_title: P-15L Bone Graft </p>]]></description></item><item><title>G170195-NCT03433391</title><pubDate>Mon, 04 Nov 2019 02:45:14 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170195-nct03433391-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170195-nct03433391-</guid><description><![CDATA[<p>approval_date: Thu, 12 Apr 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170195</p><p>nct_number: NCT03433391</p><p>sponsor_name: FzioMed</p><p>study_title: Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery	</p>]]></description></item><item><title>GORE PV1 Device</title><pubDate>Mon, 04 Nov 2019 02:45:11 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170289-nct03441971-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170289-nct03441971-</guid><description><![CDATA[<p>approval_date: Wed, 04 Apr 2018 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03441971?term=NCT03441971&rank=1title:</p><p>ide_number: G170289</p><p>nct_number: NCT03441971</p><p>sponsor_name: W. L. Gore &#x26; Associates </p><p>study_title: GORE PV1 Device</p>]]></description></item><item><title>Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor</title><pubDate>Mon, 04 Nov 2019 02:45:07 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170302-nct03051178-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170302-nct03051178-</guid><description><![CDATA[<p>approval_date: Wed, 04 Apr 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: G170302</p><p>nct_number: NCT03051178</p><p>sponsor_name: University of Florida </p><p>study_title: Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor</p>]]></description></item><item><title>Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study</title><pubDate>Mon, 04 Nov 2019 02:45:06 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170191-nct03446833-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170191-nct03446833-</guid><description><![CDATA[<p>approval_date: Wed, 04 Apr 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170191</p><p>nct_number: NCT03446833</p><p>sponsor_name: MedtronicNeuro</p><p>study_title: Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study</p>]]></description></item><item><title>Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma</title><pubDate>Mon, 04 Nov 2019 02:45:06 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170288-nct03377491-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170288-nct03377491-</guid><description><![CDATA[<p>approval_date: Wed, 04 Apr 2018 12:00:00 -0400</p><p>category: A</p><p>ide_number: G170288</p><p>nct_number: NCT03377491</p><p>sponsor_name: NovoCure Ltd. </p><p>study_title: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma</p>]]></description></item><item><title>PQ Bypass System for Femoropopliteal Bypass II</title><pubDate>Mon, 04 Nov 2019 02:45:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170083-nct03119233</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170083-nct03119233</guid><description><![CDATA[<p>approval_date: Fri, 23 Mar 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170083</p><p>nct_number: NCT03119233</p><p>sponsor_name: PQ Bypass, Inc.</p><p>study_title: PQ Bypass System for Femoropopliteal Bypass II</p>]]></description></item><item><title>Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation</title><pubDate>Mon, 04 Nov 2019 02:45:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130019-nct03343535</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130019-nct03343535</guid><description><![CDATA[<p>approval_date: Fri, 23 Mar 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G130019</p><p>nct_number: NCT03343535</p><p>sponsor_name: TransMedics</p><p>study_title: Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation</p>]]></description></item><item><title>MED-EL SYNCRONY Cochlear Implant System</title><pubDate>Mon, 04 Nov 2019 02:45:00 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170111-nct03236909</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170111-nct03236909</guid><description><![CDATA[<p>approval_date: Thu, 15 Mar 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G170111</p><p>nct_number: NCT03236909</p><p>sponsor_name: MED-EL Corporation</p><p>study_title: MED-EL SYNCRONY Cochlear Implant System</p>]]></description></item><item><title>Metabolic Mapping and Cardiac Resynchronization (Aim 1)</title><pubDate>Mon, 04 Nov 2019 02:45:00 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150177-nct03420833</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150177-nct03420833</guid><description><![CDATA[<p>approval_date: Wed, 14 Mar 2018 12:00:00 -0400</p><p>category: B</p><p>ide_number: G150177</p><p>nct_number: NCT03420833</p><p>sponsor_name: Yong-Mei Cha</p><p>study_title: Metabolic Mapping and Cardiac Resynchronization (Aim 1)</p>]]></description></item><item><title>G170161-NCT03250247</title><pubDate>Mon, 04 Nov 2019 02:44:51 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170161-nct03250247-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170161-nct03250247-</guid><description><![CDATA[<p>approval_date: Tue, 27 Feb 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G170161</p><p>nct_number: NCT03250247</p><p>sponsor_name: Washington University School of Medicine </p><p>study_title: Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial	</p>]]></description></item><item><title>G170220-NCT03383666</title><pubDate>Mon, 04 Nov 2019 02:44:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170220-nct03383666-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170220-nct03383666-</guid><description><![CDATA[<p>approval_date: Tue, 27 Feb 2018 12:00:00 -0500</p><p>category: A</p><p>ide_number: G170220</p><p>nct_number: NCT03383666</p><p>sponsor_name: Pulsar Vascular </p><p>study_title: A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm	</p>]]></description></item><item><title>JETStream AtheRectomy With Adjunctive Paclitaxel-Coated BallooN Angioplasty vs Balloon AnGioplasty Followed by Paclitaxel-Coated Balloon in Treating ComplEx Denovo FemoRopopliteal Arterial Disease (JET-RANGER)	</title><pubDate>Mon, 04 Nov 2019 02:44:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170066-nct03206762-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170066-nct03206762-</guid><description><![CDATA[<p>approval_date: Thu, 08 Feb 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G170066</p><p>nct_number: NCT03206762</p><p>sponsor_name: Midwest Cardiovascular Research Foundation </p><p>study_title: JETStream AtheRectomy With Adjunctive Paclitaxel-Coated BallooN Angioplasty vs Balloon AnGioplasty Followed by Paclitaxel-Coated Balloon in Treating ComplEx Denovo FemoRopopliteal Arterial Disease (JET-RANGER)	</p>]]></description></item><item><title>Hemodynamic-GUIDEd Management of Heart Failure</title><pubDate>Mon, 04 Nov 2019 02:44:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170258-nct03387813</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170258-nct03387813</guid><description><![CDATA[<p>approval_date: Fri, 23 Feb 2018 12:00:00 -0500</p><p>category: B</p><p>ide_number: G170258</p><p>nct_number: NCT03387813</p><p>sponsor_name: Abbott</p><p>study_title: Hemodynamic-GUIDEd Management of Heart Failure</p>]]></description></item><item><title>G170284-NCT03382457</title><pubDate>Mon, 04 Nov 2019 02:44:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170284-nct03382457-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170284-nct03382457-</guid><description><![CDATA[<p>approval_date: Thu, 15 Feb 2018 12:00:00 -0500</p><p>category: A</p><p>ide_number: G170284</p><p>nct_number: NCT03382457</p><p>sponsor_name: Edwards Lifesciences </p><p>study_title: Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study	</p>]]></description></item><item><title>G110179-NCT03381677</title><pubDate>Mon, 04 Nov 2019 02:44:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g110179-nct03381677-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g110179-nct03381677-</guid><description><![CDATA[<p>approval_date: Fri, 26 Jan 2018 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03381677?term=NCT03381677&rank=1title:</p><p>ide_number: G110179</p><p>nct_number: NCT03381677</p><p>sponsor_name: Innovative Surgical Designs </p><p>study_title: A Prospective, Multi-Center, Randomized Concurrently Controlled Trial to Evaluate the Safety and Effectiveness of the Altum® Pedicle Osteotomy System for Use in Lumbar Spinal Stenosis	</p>]]></description></item><item><title>Clinical Study Protocol for the Investigation Of The Two Level Simplify Cervical Artificial Disc</title><pubDate>Mon, 04 Nov 2019 02:44:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150206-nct03123549-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150206-nct03123549-</guid><description><![CDATA[<p>approval_date: Fri, 02 Feb 2018 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03123549?term=NCT03123549&rank=1
title:</p><p>ide_number: G150206</p><p>nct_number: NCT03123549</p><p>sponsor_name: Simplify Medical Inc. </p><p>study_title: Clinical Study Protocol for the Investigation Of The Two Level Simplify® Cervical Artificial Disc</p>]]></description></item><item><title>G170238-NCT02973789</title><pubDate>Mon, 04 Nov 2019 02:44:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170238-nct02973789</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170238-nct02973789</guid><description><![CDATA[<p>approval_date: Thu, 15 Feb 2018 12:00:00 -0500</p><p>category: A</p><p>ide_number: G170238</p><p>nct_number: NCT02973789</p><p>sponsor_name: NovoCure Ltd.	</p><p>study_title: LUNAR: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure</p>]]></description></item><item><title>Double Blind, Phase I, Randomized, Parallel Group Study of Hip Decompression Compared to Hip Decompression Supplemented at the Point of Care With Adipose Derived Regenerative Cells for Bilateral Pre-Collapse Femoral Head Osteonecrosis</title><pubDate>Mon, 04 Nov 2019 02:44:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17455-nct03269409</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17455-nct03269409</guid><description><![CDATA[<p>approval_date: Fri, 26 Jan 2018 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03269409?term=NCT03269409&rank=1title:</p><p>ide_number: BB17455</p><p>nct_number: NCT03269409</p><p>sponsor_name: Mayo Clinic</p><p>study_title: Double Blind, Phase I, Randomized, Parallel Group Study of Hip Decompression Compared to Hip Decompression Supplemented at the Point of Care With Adipose Derived Regenerative Cells for Bilateral Pre-Collapse Femoral Head Osteonecrosis</p>]]></description></item><item><title>CytoSorb Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)</title><pubDate>Mon, 04 Nov 2019 02:44:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140256-nct03384875</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140256-nct03384875</guid><description><![CDATA[<p>approval_date: Fri, 02 Feb 2018 12:00:00 -0500</p><p>category: A</p><p>ide_number: G140256</p><p>nct_number: NCT03384875</p><p>sponsor_name: CytoSorbents, Inc </p><p>study_title: CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)</p>]]></description></item><item><title>Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization</title><pubDate>Mon, 04 Nov 2019 02:44:37 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170065-nct03370536</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170065-nct03370536</guid><description><![CDATA[<p>approval_date: Fri, 26 Jan 2018 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03370536?term=NCT03370536&rank=1title:</p><p>ide_number: G170065</p><p>nct_number: NCT03370536</p><p>sponsor_name: Vivek Reddy </p><p>study_title: Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization</p>]]></description></item><item><title>Pilot Study to Examine the Feasibility of the DISCSS</title><pubDate>Mon, 04 Nov 2019 02:44:36 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170169-nct03341000-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170169-nct03341000-</guid><description><![CDATA[<p>approval_date: Wed, 03 Jan 2018 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03341000title:</p><p>ide_number: G170169</p><p>nct_number: NCT03341000</p><p>sponsor_name: Meagan Medical </p><p>study_title: Pilot Study to Examine the Feasibility of the DISCSS™</p>]]></description></item><item><title>G170243-NCT03372434</title><pubDate>Mon, 04 Nov 2019 02:44:36 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170243-nct03372434-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170243-nct03372434-</guid><description><![CDATA[<p>approval_date: Fri, 19 Jan 2018 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03372434title:</p><p>ide_number: G170243</p><p>nct_number: NCT03372434</p><p>sponsor_name: Abbott Medical Optics Inc.</p><p>study_title: TECNIS® Next-Generation Intraocular Lenses (IOLs), Models ZFR00 and ZYR00 	</p>]]></description></item><item><title>Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease</title><pubDate>Mon, 04 Nov 2019 02:44:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170090-nct03301246</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170090-nct03301246</guid><description><![CDATA[<p>approval_date: Mon, 08 Jan 2018 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03301246title:</p><p>ide_number: G170090</p><p>nct_number: NCT03301246</p><p>sponsor_name: Eminence Clinical Research, Inc. </p><p>study_title: Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease</p>]]></description></item><item><title>Multi-Center Acute Safety Trial of TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation</title><pubDate>Mon, 04 Nov 2019 02:44:32 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170245-nct03354663-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170245-nct03354663-</guid><description><![CDATA[<p>approval_date: Wed, 10 Jan 2018 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03354663title:</p><p>ide_number: G170245</p><p>nct_number: NCT03354663</p><p>sponsor_name: Abbott</p><p>study_title: Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation</p>]]></description></item><item><title>G170147-NCT03339492</title><pubDate>Mon, 04 Nov 2019 02:44:31 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170147-nct03339492-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170147-nct03339492-</guid><description><![CDATA[<p>approval_date: Tue, 02 Jan 2018 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03339492title:</p><p>ide_number: G170147</p><p>nct_number: NCT03339492</p><p>sponsor_name: Orthofix, Inc. </p><p>study_title: RCStim Model 1114R or 1114L Soft Tissue Stimulator	</p>]]></description></item><item><title>Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping</title><pubDate>Mon, 04 Nov 2019 02:44:31 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170110-nct03349476-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170110-nct03349476-</guid><description><![CDATA[<p>approval_date: Wed, 10 Jan 2018 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03349476title:</p><p>ide_number: G170110</p><p>nct_number: NCT03349476</p><p>sponsor_name: Vivek Reddy </p><p>study_title: Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping</p>]]></description></item><item><title>TSolution One Total Knee Arthroplasty Clinical Trial</title><pubDate>Mon, 04 Nov 2019 02:44:30 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160094-nct03017261-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160094-nct03017261-</guid><description><![CDATA[<p>approval_date: Fri, 22 Dec 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03017261title:</p><p>ide_number: G160094 </p><p>nct_number: NCT03017261</p><p>sponsor_name: Think Surgical Inc.</p><p>study_title: TSolution One® Total Knee Arthroplasty Clinical Trial</p>]]></description></item><item><title>A Randomized Controlled Clinical Evaluation of the DiamondTemp System for the Treatment of Paroxysmal Atrial Fibrillation</title><pubDate>Mon, 04 Nov 2019 02:44:29 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170227-nct03334630</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170227-nct03334630</guid><description><![CDATA[<p>approval_date: Fri, 22 Dec 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03334630title:</p><p>ide_number: G170227</p><p>nct_number: NCT03334630</p><p>sponsor_name: Advanced Cardiac Therapeutics </p><p>study_title: A Randomized Controlled Clinical Evaluation of the DiamondTemp™ System for the Treatment of Paroxysmal Atrial Fibrillation</p>]]></description></item><item><title>Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms</title><pubDate>Mon, 04 Nov 2019 02:44:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170024-nct03075748-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170024-nct03075748-</guid><description><![CDATA[<p>approval_date: Tue, 28 Nov 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03075748title:</p><p>ide_number: G170024</p><p>nct_number: NCT03075748</p><p>sponsor_name: University of South Florida</p><p>study_title: Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms</p>]]></description></item><item><title>G170067-NCT03204981</title><pubDate>Mon, 04 Nov 2019 02:44:25 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170067-nct03204981-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170067-nct03204981-</guid><description><![CDATA[<p>approval_date: Fri, 15 Dec 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03204981title:</p><p>ide_number: G170067</p><p>nct_number: NCT03204981</p><p>sponsor_name: Vivek Reddy </p><p>study_title: Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias	</p>]]></description></item><item><title>Evaluate the Efficacy and Safety of RBCs Derived From Mirasol-treated Whole Blood Compared With Conventional RBCs in Patients Requiring Chronic Transfusion Support</title><pubDate>Mon, 04 Nov 2019 02:44:22 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb15025-nct03329404-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb15025-nct03329404-</guid><description><![CDATA[<p>approval_date: Tue, 12 Dec 2017 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03329404title:</p><p>ide_number: BB15025</p><p>nct_number: NCT03329404</p><p>sponsor_name: Terumo BCTbio</p><p>study_title: Evaluate the Efficacy and Safety of RBCs Derived From Mirasol-treated Whole Blood Compared With Conventional RBCs in Patients Requiring Chronic Transfusion Support</p>]]></description></item><item><title>A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support</title><pubDate>Mon, 04 Nov 2019 02:44:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170096-nct03255057-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170096-nct03255057-</guid><description><![CDATA[<p>approval_date: Tue, 31 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03255057title:</p><p>ide_number: G170096</p><p>nct_number: NCT03255057</p><p>sponsor_name: Alung Technologies</p><p>study_title: A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support</p>]]></description></item><item><title>Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System</title><pubDate>Mon, 04 Nov 2019 02:44:17 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150041-2-nct02471807</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150041-2-nct02471807</guid><description><![CDATA[<p>approval_date: Wed, 11 Jan 2017 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02471807?term=NCT02471807&rank=1title:</p><p>ide_number: G150041</p><p>nct_number: NCT02471807</p><p>sponsor_name: Edwards Lifesciences </p><p>study_title: Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System</p>]]></description></item><item><title>A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula</title><pubDate>Mon, 04 Nov 2019 02:44:17 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170039-nct03242343-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170039-nct03242343-</guid><description><![CDATA[<p>approval_date: Fri, 24 Nov 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03242343title:</p><p>ide_number: G170039</p><p>nct_number: NCT03242343</p><p>sponsor_name: Laminate Medical Technologies </p><p>study_title: A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula</p>]]></description></item><item><title>Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)</title><pubDate>Mon, 04 Nov 2019 02:44:14 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170118-nct03227757-1</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170118-nct03227757-1</guid><description><![CDATA[<p>approval_date: Tue, 07 Nov 2017 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03227757title:</p><p>ide_number: G170118</p><p>nct_number: NCT03227757</p><p>sponsor_name: Evalve</p><p>study_title: Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)</p>]]></description></item><item><title>G160136-NCT03083366</title><pubDate>Mon, 04 Nov 2019 02:44:13 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160136-nct03083366-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160136-nct03083366-</guid><description><![CDATA[<p>approval_date: Mon, 06 Nov 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03083366title:</p><p>ide_number: G160136</p><p>nct_number: NCT03083366</p><p>sponsor_name: University of Utah </p><p>study_title: The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury 	</p>]]></description></item><item><title>Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)</title><pubDate>Mon, 04 Nov 2019 02:44:13 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170049-nct03263702-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170049-nct03263702-</guid><description><![CDATA[<p>approval_date: Fri, 10 Nov 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03263702title:</p><p>ide_number: G170049</p><p>nct_number: NCT03263702</p><p>sponsor_name: Vivek Reddy </p><p>study_title: Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)</p>]]></description></item><item><title>SAPIEN M3 System </title><pubDate>Mon, 04 Nov 2019 02:44:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170152%253fnct03230747-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170152%253fnct03230747-</guid><description><![CDATA[<p>approval_date: Thu, 26 Oct 2017 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03230747title:</p><p>ide_number: G170152</p><p>nct_number: NCT03230747</p><p>sponsor_name: Edwards Lifesciences LLC</p><p>study_title: SAPIEN M3 System </p>]]></description></item><item><title>SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma (SIRCCA)</title><pubDate>Mon, 04 Nov 2019 02:44:03 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160128-nct02807181</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160128-nct02807181</guid><description><![CDATA[<p>approval_date: Thu, 26 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02807181title:</p><p>ide_number: G160128</p><p>nct_number: NCT02807181</p><p>sponsor_name: Sirtex Medical</p><p>study_title: SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma (SIRCCA)</p>]]></description></item><item><title>Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study (SITRAL)</title><pubDate>Mon, 04 Nov 2019 02:44:03 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160024-nct02830204-1</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160024-nct02830204-1</guid><description><![CDATA[<p>approval_date: Mon, 16 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2.show/NCT02830204title:</p><p>ide_number: G160024</p><p>nct_number: NCT02830204</p><p>sponsor_name: Baylor Research Institute</p><p>study_title: Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study (SITRAL)</p>]]></description></item><item><title>Intravascular Ventricular Assist System (iVAS)</title><pubDate>Mon, 04 Nov 2019 02:44:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150242-nct02645539-1-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150242-nct02645539-1-</guid><description><![CDATA[<p>approval_date: Mon, 23 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02645539title:</p><p>ide_number: G150242</p><p>nct_number: NCT02645539</p><p>sponsor_name: NuPulseCV, Inc.</p><p>study_title: Intravascular Ventricular Assist System (iVAS)</p>]]></description></item><item><title>AcrySof IQ PanOptix Intraocular Lens
</title><pubDate>Mon, 04 Nov 2019 02:44:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170172-nct03280108</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170172-nct03280108</guid><description><![CDATA[<p>approval_date: Thu, 26 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03280108
title:</p><p>ide_number: G170172</p><p>nct_number: NCT03280108</p><p>sponsor_name: Alcon Research, Ltd.														</p><p>study_title: AcrySof IQ PanOptix Intraocular Lens
</p>]]></description></item><item><title>Proposed Single Center Investigational Device Exemption: Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis</title><pubDate>Mon, 04 Nov 2019 02:44:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150087-nct02524834-2-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150087-nct02524834-2-</guid><description><![CDATA[<p>approval_date: Mon, 23 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02524834title:</p><p>ide_number: G150087</p><p>nct_number: NCT02524834</p><p>sponsor_name: Rodney A. White, M.D. </p><p>study_title: Proposed Single Center Investigational Device Exemption: Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis</p>]]></description></item><item><title>Randomized Trial Of Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention</title><pubDate>Mon, 04 Nov 2019 02:44:00 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170154-nct03089398-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170154-nct03089398-</guid><description><![CDATA[<p>approval_date: Fri, 22 Sep 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03089398title:</p><p>ide_number: G170154</p><p>nct_number: NCT03089398</p><p>sponsor_name: Emilia Bagiella </p><p>study_title: Randomized Trial Of Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention</p>]]></description></item><item><title>G170157-NCT03257410</title><pubDate>Mon, 04 Nov 2019 02:43:59 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170157-nct03257410-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170157-nct03257410-</guid><description><![CDATA[<p>approval_date: Wed, 11 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://www.clinicaltrials.gov/ct2/show/NCT03257410	title:</p><p>ide_number: G170157</p><p>nct_number: NCT03257410</p><p>sponsor_name: Baxter Healthcare Corporation</p><p>study_title: Theranova 400 Dialyzer</p>]]></description></item><item><title>Deep Brain Stimulation (DBS) in Patients With Refractory Chronic Neuropathic Pain</title><pubDate>Mon, 04 Nov 2019 02:43:58 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160018-nct03029884-1</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160018-nct03029884-1</guid><description><![CDATA[<p>approval_date: Wed, 11 Oct 2017 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03029884title:</p><p>ide_number: G160018</p><p>nct_number: NCT03029884</p><p>sponsor_name: University of California, San Francisco </p><p>study_title: Deep Brain Stimulation (DBS) in Patients With Refractory Chronic Neuropathic Pain</p>]]></description></item><item><title>AcrySofIQ Extended Depth of Focus (EDF) Intraocular Lens (IOL) </title><pubDate>Mon, 04 Nov 2019 02:43:58 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170175-nct03274986-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170175-nct03274986-</guid><description><![CDATA[<p>approval_date: Thu, 12 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03274986title:</p><p>ide_number: G170175</p><p>nct_number: NCT03274986</p><p>sponsor_name: Alcon Research, Ltd.</p><p>study_title: AcrySof®IQ Extended Depth of Focus (EDF) Intraocular Lens (IOL) </p>]]></description></item><item><title>Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms</title><pubDate>Mon, 04 Nov 2019 02:43:55 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170048-nct03246126</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170048-nct03246126</guid><description><![CDATA[<p>approval_date: Tue, 12 Sep 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03246126title:</p><p>ide_number: G170048</p><p>nct_number: NCT03246126</p><p>sponsor_name: New York University School of Medicine </p><p>study_title: Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms</p>]]></description></item><item><title>Intrepid Transcatheter Mitral Valve Replacement System </title><pubDate>Mon, 04 Nov 2019 02:43:53 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160020-nct03242642-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160020-nct03242642-</guid><description><![CDATA[<p>approval_date: Tue, 26 Sep 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03242642title:</p><p>ide_number: G160020</p><p>nct_number: NCT03242642</p><p>sponsor_name: Medtronics</p><p>study_title: Intrepid Transcatheter Mitral Valve Replacement System </p>]]></description></item><item><title>INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries</title><pubDate>Mon, 04 Nov 2019 02:43:53 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170078-nct03192696-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170078-nct03192696-</guid><description><![CDATA[<p>approval_date: Tue, 03 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03192696title:</p><p>ide_number: G170078</p><p>nct_number: NCT03192696</p><p>sponsor_name: Avinger, Inc. </p><p>study_title: INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries</p>]]></description></item><item><title>G150121-NCT03241459-2</title><pubDate>Mon, 04 Nov 2019 02:43:52 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150121-nct03241459-2</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150121-nct03241459-2</guid><description><![CDATA[<p>approval_date: Tue, 03 Oct 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03241459title:</p><p>ide_number: G150121</p><p>nct_number: NCT03241459</p><p>sponsor_name: SurModics, Inc.</p><p>study_title: The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon iN the Treatment of Subjects With Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon</p>]]></description></item><item><title>Safety and Effectiveness Evaluation of Eximo Medical's B-LaserTM, a Hybrid Atherectomy Device, in Subjects Affected with Infrainguinal PAD</title><pubDate>Mon, 04 Nov 2019 02:43:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170104-nct03157531</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170104-nct03157531</guid><description><![CDATA[<p>approval_date: Wed, 20 Sep 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03157531title:</p><p>ide_number: G170104</p><p>nct_number: NCT03157531</p><p>sponsor_name: Eximo Medical Ltd </p><p>study_title: Safety and Effectiveness Evaluation of Eximo Medical's B-LaserTM, a Hybrid Atherectomy Device, in Subjects Affected with Infrainguinal PAD</p>]]></description></item><item><title>Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms</title><pubDate>Mon, 04 Nov 2019 02:43:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160207-nct02989948</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160207-nct02989948</guid><description><![CDATA[<p>approval_date: Fri, 08 Sep 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02989948title:</p><p>ide_number: G160207</p><p>nct_number: NCT02989948</p><p>sponsor_name: University of Colorado, Denver </p><p>study_title: Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms</p>]]></description></item><item><title>A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Probable Benefit of the KeraKlear Non-Penetrating Keratoprosthesis in Subjects With Corneal Opacity With Poor Prognosis for Corneal Transplant</title><pubDate>Mon, 04 Nov 2019 02:43:46 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150267-nct03126903-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150267-nct03126903-</guid><description><![CDATA[<p>approval_date: Fri, 08 Sep 2017 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03126903title:</p><p>ide_number: G150267</p><p>nct_number: NCT03126903</p><p>sponsor_name: KeraMed, Inc.</p><p>study_title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Probable Benefit of the KeraKlear Non-Penetrating Keratoprosthesis in Subjects With Corneal Opacity With Poor Prognosis for Corneal Transplant</p>]]></description></item><item><title>A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo Aspiration System in Acute Submassive Pulmonary Embolism</title><pubDate>Mon, 04 Nov 2019 02:43:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170064-nct03218566</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170064-nct03218566</guid><description><![CDATA[<p>approval_date: Fri, 08 Sep 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03218566title:</p><p>ide_number: G170064</p><p>nct_number: NCT03218566</p><p>sponsor_name: Penumbra Inc. </p><p>study_title: A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo Aspiration System in Acute Submassive Pulmonary Embolism</p>]]></description></item><item><title>XIENCE Short DAPT Study</title><pubDate>Mon, 04 Nov 2019 02:43:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170081-nct03218787</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170081-nct03218787</guid><description><![CDATA[<p>approval_date: Thu, 24 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03218787title:</p><p>ide_number: G170081</p><p>nct_number: NCT03218787</p><p>sponsor_name: Abbott Vascular </p><p>study_title: XIENCE Short DAPT Study</p>]]></description></item><item><title>A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support</title><pubDate>Mon, 04 Nov 2019 02:43:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150225-nct03209609</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150225-nct03209609</guid><description><![CDATA[<p>approval_date: Thu, 10 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03209609title:</p><p>ide_number: G150225</p><p>nct_number: NCT03209609</p><p>sponsor_name: Vascular Graft Solutions Ltd. </p><p>study_title: A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support</p>]]></description></item><item><title>Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL)</title><pubDate>Mon, 04 Nov 2019 02:43:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170112-nct03170154-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170112-nct03170154-</guid><description><![CDATA[<p>approval_date: Thu, 10 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03170154title:</p><p>ide_number: G170112</p><p>nct_number: NCT03170154</p><p>sponsor_name: Alcon Laboratories, Inc.</p><p>study_title: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL)</p>]]></description></item><item><title>Epidural Stimulation for Spinal Cord Injury</title><pubDate>Mon, 04 Nov 2019 02:43:40 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160247-nct03026816-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160247-nct03026816-</guid><description><![CDATA[<p>approval_date: Wed, 30 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03026816title:</p><p>ide_number: G160247</p><p>nct_number: NCT03026816</p><p>sponsor_name: University of Minnesota - Clinical and Translational Science Institute </p><p>study_title: Epidural Stimulation for Spinal Cord Injury</p>]]></description></item><item><title>PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve</title><pubDate>Mon, 04 Nov 2019 02:43:40 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150278-nct03193801-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150278-nct03193801-</guid><description><![CDATA[<p>approval_date: Fri, 25 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03193801title:</p><p>ide_number: G150278</p><p>nct_number: NCT03193801</p><p>sponsor_name: Edwards Lifesciences </p><p>study_title: PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve</p>]]></description></item><item><title>A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery</title><pubDate>Mon, 04 Nov 2019 02:43:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160237-nct03214601-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160237-nct03214601-</guid><description><![CDATA[<p>approval_date: Fri, 18 Aug 2017 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03214601title:</p><p>ide_number: G160237</p><p>nct_number: NCT03214601</p><p>sponsor_name: Bolton Medical </p><p>study_title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery</p>]]></description></item><item><title>G160235-NCT03168776</title><pubDate>Mon, 04 Nov 2019 02:43:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160235-nct03168776-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160235-nct03168776-</guid><description><![CDATA[<p>approval_date: Tue, 22 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03168776title:</p><p>ide_number: G160235</p><p>nct_number: NCT03168776</p><p>sponsor_name: Sino Medical Sciences Technology Inc.</p><p>study_title: A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients With Stable Coronary Artery Disease or Non-ST Segment Elevation Acute Coronary Syndromes</p>]]></description></item><item><title>G160227-NCT03190473</title><pubDate>Mon, 04 Nov 2019 02:43:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160227-nct03190473-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160227-nct03190473-</guid><description><![CDATA[<p>approval_date: Fri, 18 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03190473title:</p><p>ide_number: G160227</p><p>nct_number: NCT03190473</p><p>sponsor_name: Svelte Medical Systems, Inc.</p><p>study_title: The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study	</p>]]></description></item><item><title>G150271-NCT03076216</title><pubDate>Mon, 04 Nov 2019 02:43:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150271-nct03076216</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150271-nct03076216</guid><description><![CDATA[<p>approval_date: Thu, 17 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03076216	title:</p><p>ide_number: G150271</p><p>nct_number: NCT03076216</p><p>sponsor_name: OncoSil Medical Limited </p><p>study_title: An Open Label, Single Arm Pilot Study of OncoSil™, Administered to Subjects With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With Gemcitabine or Gemcitabine+Nab-paclitaxel Chemotherapies</p>]]></description></item><item><title>Multicenter Early Feasibility Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 Transcather Heart Valve With the Alterra Adaptive Prestent</title><pubDate>Mon, 04 Nov 2019 02:43:35 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170053-nct03130777</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170053-nct03130777</guid><description><![CDATA[<p>approval_date: Fri, 21 Jul 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03130777title:</p><p>ide_number: G170053</p><p>nct_number: NCT03130777</p><p>sponsor_name: Edwards Lifesciences </p><p>study_title: Multicenter Early Feasibility Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 Transcather Heart Valve With the Alterra Adaptive Prestent</p>]]></description></item><item><title>Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST - MST)</title><pubDate>Mon, 04 Nov 2019 02:43:34 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170127-nct03191058-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170127-nct03191058-</guid><description><![CDATA[<p>approval_date: Thu, 03 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03191058title:</p><p>ide_number: G170127</p><p>nct_number: NCT03191058</p><p>sponsor_name: University of Texas Southwestern Medical Center </p><p>study_title: Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST - MST)</p>]]></description></item><item><title>Prospective, Randomized, Double-Blinded, Controlled Multi-Center Clinical Trial Evaluating the Use of Non-Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures</title><pubDate>Mon, 04 Nov 2019 02:43:32 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150262-nct02688855-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150262-nct02688855-</guid><description><![CDATA[<p>approval_date: Thu, 10 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02688855title:</p><p>ide_number: G150262</p><p>nct_number: NCT02688855</p><p>sponsor_name: Encore Medical, L.P.</p><p>study_title: Prospective, Randomized, Double-Blinded, Controlled Multi-Center Clinical Trial Evaluating the Use of Non-Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures</p>]]></description></item><item><title>Cardiva Mid-Bore Venous Vascular Closure System (VVCS)</title><pubDate>Mon, 04 Nov 2019 02:43:31 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170144-nct03193021</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170144-nct03193021</guid><description><![CDATA[<p>approval_date: Thu, 03 Aug 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03193021title:</p><p>ide_number: G170144</p><p>nct_number: NCT03193021</p><p>sponsor_name: Cardiva Medical, Inc.</p><p>study_title: Cardiva Mid-Bore Venous Vascular Closure System (VVCS)</p>]]></description></item><item><title>Evaluation of the Surfacer System Approach to Central Venous Access</title><pubDate>Mon, 04 Nov 2019 02:43:31 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170045-nct03209050-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170045-nct03209050-</guid><description><![CDATA[<p>approval_date: Thu, 03 Aug 2017 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03209050title:</p><p>ide_number: G170045</p><p>nct_number: NCT03209050</p><p>sponsor_name: Bluegrass Vascular Technologies </p><p>study_title: Evaluation of the Surfacer System Approach to Central Venous Access</p>]]></description></item><item><title>Cardioband Mitral System</title><pubDate>Mon, 04 Nov 2019 02:43:25 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160246-nct03016975</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160246-nct03016975</guid><description><![CDATA[<p>approval_date: Thu, 22 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03016975?term=NCT03016975&rank=1title:</p><p>ide_number: G160246</p><p>nct_number: NCT03016975</p><p>sponsor_name: Edwards Lifesciences Corporation</p><p>study_title: Cardioband Mitral System</p>]]></description></item><item><title>Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders</title><pubDate>Mon, 04 Nov 2019 02:43:24 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17240-nct03093844</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17240-nct03093844</guid><description><![CDATA[<p>approval_date: Fri, 07 Jul 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03093844
title:</p><p>ide_number: BB17240</p><p>nct_number: NCT03093844</p><p>sponsor_name: University of Colorado, Denever</p><p>study_title: Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders</p>]]></description></item><item><title>Operative Procedures vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial (OPEN-UP)</title><pubDate>Mon, 04 Nov 2019 02:43:21 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160232-nct02513914</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160232-nct02513914</guid><description><![CDATA[<p>approval_date: Thu, 22 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02513914title:</p><p>ide_number: G160232</p><p>nct_number: NCT02513914</p><p>sponsor_name: St. Joseph's Hospital and Medical Center, Phoenix </p><p>study_title: Operative Procedures vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial (OPEN-UP)</p>]]></description></item><item><title>Medtronic TAAA Debranching Stent Graft System</title><pubDate>Mon, 04 Nov 2019 02:43:21 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160182-nct03113383-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160182-nct03113383-</guid><description><![CDATA[<p>approval_date: Thu, 22 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03113383?term=NCT03113383&rank=1title:</p><p>ide_number: G160182</p><p>nct_number: NCT03113383</p><p>sponsor_name: Vanderbilt University Medical Center </p><p>study_title: Medtronic TAAA Debranching Stent Graft System</p>]]></description></item><item><title>Attain Stability Quad Clinical Study</title><pubDate>Mon, 04 Nov 2019 02:43:21 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170020-nct03099655</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170020-nct03099655</guid><description><![CDATA[<p>approval_date: Thu, 22 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03099655?term=NCT03099655&rank=1title:</p><p>ide_number: G170020</p><p>nct_number: NCT03099655</p><p>sponsor_name: Medtronic Cardiac Rhythm and Heart Failure</p><p>study_title: Attain Stability™ Quad Clinical Study</p>]]></description></item><item><title>G160183-NCT03141255</title><pubDate>Mon, 04 Nov 2019 02:43:20 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160183-nct03141255-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160183-nct03141255-</guid><description><![CDATA[<p>approval_date: Thu, 22 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03141255?term=NCT03141255&rank=1title:</p><p>ide_number: G160183</p><p>nct_number: NCT03141255</p><p>sponsor_name: University of Chicago </p><p>study_title: Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK)	</p>]]></description></item><item><title>Assessment of the Carillon Mitral Contour System in Treating Functional Mitral Regurgitation Associated With Heart Failure</title><pubDate>Mon, 04 Nov 2019 02:43:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160223-nct03142152-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160223-nct03142152-</guid><description><![CDATA[<p>approval_date: Tue, 06 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03142152?term=NCT03142152&rank=1title:</p><p>ide_number: G160223</p><p>nct_number: NCT03142152</p><p>sponsor_name: Cardiac Dimensions Pty Ltd </p><p>study_title: Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure</p>]]></description></item><item><title>STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation</title><pubDate>Mon, 04 Nov 2019 02:43:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160219-nct03118518-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160219-nct03118518-</guid><description><![CDATA[<p>approval_date: Tue, 06 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03118518?term=NCT03118518&rank=1title:</p><p>ide_number: G160219</p><p>nct_number: NCT03118518</p><p>sponsor_name: Medtronic Atrial Fibrillation Solutions </p><p>study_title: STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation</p>]]></description></item><item><title>Deep Brain Stimulation to Relieve Depression</title><pubDate>Mon, 04 Nov 2019 02:43:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160025-nct02889250</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160025-nct02889250</guid><description><![CDATA[<p>approval_date: Thu, 08 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02889250title:</p><p>ide_number: G160025</p><p>nct_number: NCT02889250</p><p>sponsor_name: University of Pittsburgh</p><p>study_title: Deep Brain Stimulation to Relieve Depression</p>]]></description></item><item><title>RELIEF Study: A Prospective, Multicenter Study of REflux Management With the LINX System for Gastroesophageal REFlux Disease After Laparoscopic Sleeve Gastrectomy</title><pubDate>Mon, 04 Nov 2019 02:43:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160170-nct02429830</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160170-nct02429830</guid><description><![CDATA[<p>approval_date: Tue, 06 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02429830?term=NCT02429830&rank=1title:</p><p>ide_number: G160170</p><p>nct_number: NCT02429830</p><p>sponsor_name: Torax Medical Incorporated</p><p>study_title: RELIEF Study: A Prospective, Multicenter Study of REflux Management With the LINX® System for Gastroesophageal REFlux Disease After Laparoscopic Sleeve Gastrectomy</p>]]></description></item><item><title>Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)</title><pubDate>Mon, 04 Nov 2019 02:43:15 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170036-nct03111459</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170036-nct03111459</guid><description><![CDATA[<p>approval_date: Mon, 05 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03111459?term=NCT03111459&rank=1title:</p><p>ide_number: G170036</p><p>nct_number: NCT03111459</p><p>sponsor_name: The Christ Hospital </p><p>study_title: Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)</p>]]></description></item><item><title>Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II</title><pubDate>Mon, 04 Nov 2019 02:43:14 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170027-nct03123250</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170027-nct03123250</guid><description><![CDATA[<p>approval_date: Mon, 05 Jun 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03123250?term=NCT03123250&rank=1title:</p><p>ide_number: G170027</p><p>nct_number: NCT03123250</p><p>sponsor_name: PROCEPT BioRobotics </p><p>study_title: Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II</p>]]></description></item><item><title>A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse Bone Graft With Mastergraft Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions</title><pubDate>Mon, 04 Nov 2019 02:43:13 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160139-nct03118505-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160139-nct03118505-</guid><description><![CDATA[<p>approval_date: Fri, 26 May 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03118505?term=NCT03118505&rank=1title:</p><p>ide_number: G160139</p><p>nct_number: NCT03118505</p><p>sponsor_name: Medtronic Spinal and Biologics </p><p>study_title: A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions</p>]]></description></item><item><title>Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial</title><pubDate>Mon, 04 Nov 2019 02:43:13 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140244-nct03052920</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140244-nct03052920</guid><description><![CDATA[<p>approval_date: Fri, 26 May 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03052920title:</p><p>ide_number: G140244</p><p>nct_number: NCT03052920</p><p>sponsor_name: Washington University School of Medicine </p><p>study_title: Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial</p>]]></description></item><item><title>Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters.</title><pubDate>Mon, 04 Nov 2019 02:43:09 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170007-nct03052530</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170007-nct03052530</guid><description><![CDATA[<p>approval_date: Mon, 24 Apr 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03052530title:</p><p>ide_number: G170007</p><p>nct_number: NCT03052530</p><p>sponsor_name: OrbusNeich </p><p>study_title: Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters.</p>]]></description></item><item><title>Revolution Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization</title><pubDate>Mon, 04 Nov 2019 02:43:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160267-nct02961894</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160267-nct02961894</guid><description><![CDATA[<p>approval_date: Wed, 10 May 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02961894?term=NCT02961894&rank=1title:</p><p>ide_number: G160267</p><p>nct_number: NCT02961894</p><p>sponsor_name: Rex Medical </p><p>study_title: Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization</p>]]></description></item><item><title>TECNIS Next-Generation Intraocular Lens, Models ZHR00 and ZQR00</title><pubDate>Mon, 04 Nov 2019 02:43:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170055-nct03111550</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g170055-nct03111550</guid><description><![CDATA[<p>approval_date: Wed, 10 May 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03111550title:</p><p>ide_number: G170055</p><p>nct_number: NCT03111550</p><p>sponsor_name: Abbott Medical Optics Inc.</p><p>study_title: TECNIS Next-Generation Intraocular Lens, Models ZHR00 and ZQR00</p>]]></description></item><item><title>Corvia Medical Interatrial Shunt Device (IASD) System II</title><pubDate>Mon, 04 Nov 2019 02:43:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150210-nct03088033</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150210-nct03088033</guid><description><![CDATA[<p>approval_date: Wed, 10 May 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03088033?term=NCT03088033&rank=1title:</p><p>ide_number: G150210</p><p>nct_number: NCT03088033</p><p>sponsor_name: Corvia Medical, Inc.</p><p>study_title: Corvia Medical Interatrial Shunt Device (IASD) System II</p>]]></description></item><item><title>Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy</title><pubDate>Mon, 04 Nov 2019 02:43:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17214-nct02961699</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb17214-nct02961699</guid><description><![CDATA[<p>approval_date: Wed, 26 Apr 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02961699title:</p><p>ide_number: BB17214</p><p>nct_number: NCT02961699</p><p>sponsor_name: InGeneron, Inc.</p><p>study_title: Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy</p>]]></description></item><item><title>Impact of Fever Prevention in Brain Injured Patients</title><pubDate>Mon, 04 Nov 2019 02:43:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160108-nct02996266</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160108-nct02996266</guid><description><![CDATA[<p>approval_date: Tue, 18 Apr 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02996266?term=NCT02996266&rank=1title:</p><p>ide_number: G160108</p><p>nct_number: NCT02996266</p><p>sponsor_name: C. R. Bard</p><p>study_title: Impact of Fever Prevention in Brain Injured Patients</p>]]></description></item><item><title>Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas</title><pubDate>Mon, 04 Nov 2019 02:43:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160266-nct02923011-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160266-nct02923011-</guid><description><![CDATA[<p>approval_date: Wed, 03 May 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02923011?term=NCT02923011&rank=1
title:</p><p>ide_number: G160266</p><p>nct_number: NCT02923011</p><p>sponsor_name: Matthew Bucknor </p><p>study_title: Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas</p>]]></description></item><item><title>Abre Venous Self-Expanding Stent System</title><pubDate>Mon, 04 Nov 2019 02:43:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160163-nct03038438-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160163-nct03038438-</guid><description><![CDATA[<p>approval_date: Wed, 03 May 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03038438?term=NCT03038438&rank=1title:</p><p>ide_number: G160163</p><p>nct_number: NCT03038438</p><p>sponsor_name: Medtronic</p><p>study_title: Abre Venous Self-Expanding Stent System</p>]]></description></item><item><title>Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study</title><pubDate>Mon, 04 Nov 2019 02:42:59 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160197-nct03000270</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160197-nct03000270</guid><description><![CDATA[<p>approval_date: Fri, 14 Apr 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03000270title:</p><p>ide_number: G160197</p><p>nct_number: NCT03000270</p><p>sponsor_name: ABIOMED</p><p>study_title: Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study</p>]]></description></item><item><title>Aluvra</title><pubDate>Mon, 04 Nov 2019 02:42:59 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160238-nct03090607</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160238-nct03090607</guid><description><![CDATA[<p>approval_date: Mon, 24 Apr 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03090607?term=NCT03090607&rank=1title:</p><p>ide_number: G160238</p><p>nct_number: NCT03090607</p><p>sponsor_name: Impleo Medical, Inc.</p><p>study_title: Aluvra</p>]]></description></item><item><title>G160213-NCT02998229</title><pubDate>Mon, 04 Nov 2019 02:42:58 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160213-nct02998229</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160213-nct02998229</guid><description><![CDATA[<p>approval_date: Mon, 20 Mar 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02998229	title:</p><p>ide_number: G160213</p><p>nct_number: NCT02998229</p><p>sponsor_name: Medtronic</p><p>study_title: Artisse Intrasaccular Device</p>]]></description></item><item><title>Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)</title><pubDate>Mon, 04 Nov 2019 02:42:58 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160263-nct03065647</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160263-nct03065647</guid><description><![CDATA[<p>approval_date: Fri, 14 Apr 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03065647?term=NCT03065647&rank=1title:</p><p>ide_number: G160263</p><p>nct_number: NCT03065647</p><p>sponsor_name: University of Michigan</p><p>study_title: Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)</p>]]></description></item><item><title>STOP Persistent AF</title><pubDate>Mon, 04 Nov 2019 02:42:56 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160177-nct03012841</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160177-nct03012841</guid><description><![CDATA[<p>approval_date: Mon, 17 Apr 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03012841title:</p><p>ide_number: G160177</p><p>nct_number: NCT03012841</p><p>sponsor_name: Medtronic Atrial Fibrillation Solutions</p><p>study_title: STOP Persistent AF</p>]]></description></item><item><title>Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)</title><pubDate>Mon, 04 Nov 2019 02:42:55 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160004-nct02930889</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160004-nct02930889</guid><description><![CDATA[<p>approval_date: Mon, 03 Apr 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02930889?term=NCT02930889&rank=1title:</p><p>ide_number: G160004</p><p>nct_number: NCT02930889</p><p>sponsor_name: University of Minnesota - Clinical and Translational Science Institute</p><p>study_title: Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)</p>]]></description></item><item><title>Da Vinci SP Surgical System, Endowrist SP Instruments, and Accessories</title><pubDate>Mon, 04 Nov 2019 02:42:55 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160251-nct03049280</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160251-nct03049280</guid><description><![CDATA[<p>approval_date: Tue, 04 Apr 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03049280title:</p><p>ide_number: G160251</p><p>nct_number: NCT03049280</p><p>sponsor_name: Intuitive Surgical, Inc.</p><p>study_title: Da Vinci SP Surgical System, Endowrist SP Instruments, and Accessories</p>]]></description></item><item><title>IN.PACT AV Access Paclitaxel-Coated PTA Balloon Catheter</title><pubDate>Mon, 04 Nov 2019 02:42:52 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160242-nct03041467-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160242-nct03041467-</guid><description><![CDATA[<p>approval_date: Mon, 20 Mar 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03041467?term=NCT03041467&rank=1title:</p><p>ide_number: G160242</p><p>nct_number: NCT03041467</p><p>sponsor_name: Medtronic Vascular, Inc.</p><p>study_title: IN.PACT AV Access Paclitaxel-Coated PTA Balloon Catheter</p>]]></description></item><item><title>A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS System</title><pubDate>Mon, 04 Nov 2019 02:42:52 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160168-nct03012776</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160168-nct03012776</guid><description><![CDATA[<p>approval_date: Thu, 02 Mar 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03012776title:</p><p>ide_number: G160168</p><p>nct_number: NCT03012776</p><p>sponsor_name: Premia Spine </p><p>study_title: A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System</p>]]></description></item><item><title>A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle</title><pubDate>Mon, 04 Nov 2019 02:42:51 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150153-nct03028415</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150153-nct03028415</guid><description><![CDATA[<p>approval_date: Wed, 15 Mar 2017 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03028415title:</p><p>ide_number: G150153</p><p>nct_number: NCT03028415</p><p>sponsor_name: Ferring Pharmaceuticals </p><p>study_title: A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX® Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle</p>]]></description></item><item><title>LEADERS FREE II: BioFreedom Pivotal Study</title><pubDate>Mon, 04 Nov 2019 02:42:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130034-nct02843633</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130034-nct02843633</guid><description><![CDATA[<p>approval_date: Tue, 07 Mar 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02843633title:</p><p>ide_number: G130034</p><p>nct_number: NCT02843633</p><p>sponsor_name: Biosensors Europe SA</p><p>study_title: LEADERS FREE II: BioFreedom Pivotal Study</p>]]></description></item><item><title>G160214-NCT03055624</title><pubDate>Mon, 04 Nov 2019 02:42:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160214-nct03055624</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160214-nct03055624</guid><description><![CDATA[<p>approval_date: Tue, 21 Mar 2017 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT03055624title:</p><p>ide_number: G160214</p><p>nct_number: NCT03055624</p><p>sponsor_name: University of California, San Diego </p><p>study_title: Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia	</p>]]></description></item><item><title>G160013-NCT02931240</title><pubDate>Mon, 04 Nov 2019 02:42:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160013-nct02931240</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160013-nct02931240</guid><description><![CDATA[<p>approval_date: Thu, 09 Mar 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02931240	title:</p><p>ide_number: G160013</p><p>nct_number: NCT02931240</p><p>sponsor_name: BioVentrix</p><p>study_title: Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms</p>]]></description></item><item><title>A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration.</title><pubDate>Mon, 04 Nov 2019 02:42:46 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160121-nct03011554</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160121-nct03011554</guid><description><![CDATA[<p>approval_date: Mon, 06 Feb 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://www.clinicaltrials.gov/ct2/show/NCT03011554?term=NCT03011554&rank=1title:</p><p>ide_number: G160121</p><p>nct_number: NCT03011554</p><p>sponsor_name: VisionCare, Inc.</p><p>study_title: A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration.</p>]]></description></item><item><title>A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA) – RANGER II SFABoston Scientific Corp.</title><pubDate>Mon, 04 Nov 2019 02:42:46 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160172-nct03064126</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160172-nct03064126</guid><description><![CDATA[<p>approval_date: Thu, 02 Mar 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT03064126title:</p><p>ide_number: G160172</p><p>nct_number: NCT03064126</p><p>sponsor_name: Boston Scientific Corp.</p><p>study_title: A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA) – RANGER II SFABoston Scientific Corp.</p>]]></description></item><item><title>Mitral Valve Repair Clinical Trial (MAVERIC Trial)</title><pubDate>Mon, 04 Nov 2019 02:42:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160098-nct02302872</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160098-nct02302872</guid><description><![CDATA[<p>approval_date: Thu, 23 Feb 2017 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02302872?term=NCT02302872&rank=1title:</p><p>ide_number: G160098</p><p>nct_number: NCT02302872</p><p>sponsor_name: Mvrx, Inc.</p><p>study_title: Mitral Valve Repair Clinical Trial (MAVERIC Trial)</p>]]></description></item><item><title>MASTER</title><pubDate>Mon, 04 Nov 2019 02:42:44 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160132-nct02972892</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160132-nct02972892</guid><description><![CDATA[<p>approval_date: Tue, 21 Feb 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02972892title:</p><p>ide_number: G160132</p><p>nct_number: NCT02972892</p><p>sponsor_name: GE Healthcare </p><p>study_title: MASTER</p>]]></description></item><item><title>G160218-NCT02985684</title><pubDate>Mon, 04 Nov 2019 02:42:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160218-nct02985684</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160218-nct02985684</guid><description><![CDATA[<p>approval_date: Fri, 10 Feb 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02985684title:</p><p>ide_number: G160218</p><p>nct_number: NCT02985684</p><p>sponsor_name: W.L.Gore and Associates, Inc.-GORE®</p><p>study_title: Gore CARDIOFORM ASD Occluder	</p>]]></description></item><item><title>The Medtronic Harmony Transcatheter Pulmonary Valve Clinical Study</title><pubDate>Mon, 04 Nov 2019 02:42:40 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120175-nct02979587</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120175-nct02979587</guid><description><![CDATA[<p>approval_date: Tue, 07 Feb 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT02979587?term=NCT02979587&rank=1title:</p><p>ide_number: G120175</p><p>nct_number: NCT02979587</p><p>sponsor_name: Medtronic Cardiovascular</p><p>study_title: The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study</p>]]></description></item><item><title>Phase II Trial Of Optune Plus Bevacizumab In Bevacizumab-Refractory Recurrent Glioblastoma</title><pubDate>Mon, 04 Nov 2019 02:42:39 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150275-nct02743078</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150275-nct02743078</guid><description><![CDATA[<p>approval_date: Tue, 10 Jan 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02743078title:</p><p>ide_number: G150275</p><p>nct_number: NCT02743078</p><p>sponsor_name: NovoCure Ltd.</p><p>study_title: Phase II Trial Of Optune Plus Bevacizumab In Bevacizumab-Refractory Recurrent Glioblastoma</p>]]></description></item><item><title>A Prospective, Randomized Multicenter Controlled Trial of CERAMENT|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures</title><pubDate>Mon, 04 Nov 2019 02:42:39 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160150-nct02820363-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160150-nct02820363-</guid><description><![CDATA[<p>approval_date: Wed, 01 Feb 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02820363title:</p><p>ide_number: G160150</p><p>nct_number: NCT02820363</p><p>sponsor_name: BONESUPPORT</p><p>study_title: A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures</p>]]></description></item><item><title>A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma</title><pubDate>Mon, 04 Nov 2019 02:42:39 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150096-nct02512692</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150096-nct02512692</guid><description><![CDATA[<p>approval_date: Tue, 10 Jan 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02512692title:</p><p>ide_number: G150096</p><p>nct_number: NCT02512692</p><p>sponsor_name: Medical University of South Carolina</p><p>study_title: A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma</p>]]></description></item><item><title>Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)</title><pubDate>Mon, 04 Nov 2019 02:42:36 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160113-nct02939976</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160113-nct02939976</guid><description><![CDATA[<p>approval_date: Tue, 31 Jan 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02939976title:</p><p>ide_number: G160113</p><p>nct_number: NCT02939976</p><p>sponsor_name: Duke/ Medtronic/Terumo/Volcano</p><p>study_title: Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)</p>]]></description></item><item><title>Clinical Effectiveness of Conventional Versus Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia</title><pubDate>Mon, 04 Nov 2019 02:42:35 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16116-nct02964325</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16116-nct02964325</guid><description><![CDATA[<p>approval_date: Mon, 23 Jan 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02964325?term=NCT02964325&rank=1title:</p><p>ide_number: BB16116</p><p>nct_number: NCT02964325</p><p>sponsor_name: Terumo BCT Biotechnologies</p><p>study_title: Clinical Effectiveness of Conventional Versus Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia</p>]]></description></item><item><title>G160226-NCT02949297</title><pubDate>Mon, 04 Nov 2019 02:42:35 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160226-nct02949297-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160226-nct02949297-</guid><description><![CDATA[<p>approval_date: Mon, 23 Jan 2017 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02949297		title:</p><p>ide_number: G160226</p><p>nct_number: NCT02949297</p><p>sponsor_name: Endologix, Inc.</p><p>study_title: Ovation Alto Abdominal Stent Graft System</p>]]></description></item><item><title>International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)</title><pubDate>Mon, 04 Nov 2019 02:42:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140192%253f-nct02522871-2</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140192%253f-nct02522871-2</guid><description><![CDATA[<p>approval_date: Tue, 20 Dec 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT02522871title:</p><p>ide_number: G140192</p><p>nct_number: NCT02522871</p><p>sponsor_name: TransMedics </p><p>study_title: International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)</p>]]></description></item><item><title>Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System</title><pubDate>Mon, 04 Nov 2019 02:42:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160144-nct02942966</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160144-nct02942966</guid><description><![CDATA[<p>approval_date: Mon, 05 Dec 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02942966?term=NCT02942966&rank=1
-title:</p><p>ide_number: G160144</p><p>nct_number: NCT02942966</p><p>sponsor_name: Intact Vascular</p><p>study_title: Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®</p>]]></description></item><item><title>A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions</title><pubDate>Mon, 04 Nov 2019 02:42:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160085-nct02924857</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160085-nct02924857</guid><description><![CDATA[<p>approval_date: Wed, 23 Nov 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02924857title:</p><p>ide_number: G160085</p><p>nct_number: NCT02924857</p><p>sponsor_name: TriReme Medical, LLC </p><p>study_title: A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions</p>]]></description></item><item><title>Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US</title><pubDate>Mon, 04 Nov 2019 02:42:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160110-nct02835950</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160110-nct02835950</guid><description><![CDATA[<p>approval_date: Thu, 17 Nov 2016 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02835950title:</p><p>ide_number: G160110</p><p>nct_number: NCT02835950</p><p>sponsor_name: SoniVie Ltd. </p><p>study_title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US</p>]]></description></item><item><title>Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears</title><pubDate>Mon, 04 Nov 2019 02:42:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16956-nct02918136</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16956-nct02918136</guid><description><![CDATA[<p>approval_date: Mon, 05 Dec 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02918136?term=NCT02918136&rank=1title:</p><p>ide_number: BB16956</p><p>nct_number: NCT02918136</p><p>sponsor_name: InGeneron, Inc.</p><p>study_title: Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears</p>]]></description></item><item><title>A Feasibility Study of Sequential Hepatic Internal Radiation and Systemic Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastatic to Liver.</title><pubDate>Mon, 04 Nov 2019 02:42:19 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150186-nct02913417</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150186-nct02913417</guid><description><![CDATA[<p>approval_date: Mon, 05 Dec 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02913417?term=NCT02913417&rank=1title:</p><p>ide_number: G150186</p><p>nct_number: NCT02913417</p><p>sponsor_name: David Minor, MD</p><p>study_title: A Feasibility Study of Sequential Hepatic Internal Radiation and Systemic Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastatic to Liver.</p>]]></description></item><item><title>Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients, SOLVE CRT</title><pubDate>Mon, 04 Nov 2019 02:42:15 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150244-nct02922036</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150244-nct02922036</guid><description><![CDATA[<p>approval_date: Tue, 01 Nov 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02922036?term=NCT02922036&rank=1title:</p><p>ide_number: G150244</p><p>nct_number: NCT02922036</p><p>sponsor_name: EBR Systems, Inc. </p><p>study_title: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients, SOLVE CRT</p>]]></description></item><item><title>G150192-NCT02676544</title><pubDate>Mon, 04 Nov 2019 02:42:15 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150192-nct02676544</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150192-nct02676544</guid><description><![CDATA[<p>approval_date: Thu, 17 Nov 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02676544?term=NCT02676544&rank=1title:</p><p>ide_number: G150192</p><p>nct_number: NCT02676544</p><p>sponsor_name: Rhode Island Hospital</p><p>study_title: Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)	</p>]]></description></item><item><title>G150157-NCT02907385</title><pubDate>Mon, 04 Nov 2019 02:42:14 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150157-nct02907385-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150157-nct02907385-</guid><description><![CDATA[<p>approval_date: Tue, 08 Nov 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02907385?term=NCT02907385&rank=1	title:</p><p>ide_number: G150157</p><p>nct_number: NCT02907385</p><p>sponsor_name: LifeBond Ltd. </p><p>study_title: Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study</p>]]></description></item><item><title>Multi-Center, Prospective, Randomized, Controlled Clinical Evaluation of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in Canaloplasty Versus Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle</title><pubDate>Mon, 04 Nov 2019 02:42:13 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160064-nct02928289-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160064-nct02928289-</guid><description><![CDATA[<p>approval_date: Tue, 08 Nov 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02928289?term=NCT02928289&rank=1title:</p><p>ide_number: G160064</p><p>nct_number: NCT02928289</p><p>sponsor_name: Sight Sciences, Inc.</p><p>study_title: Multi-Center, Prospective, Randomized, Controlled Clinical Evaluation of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in Canaloplasty Versus Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma</p>]]></description></item><item><title>Closing the Loop on Tremor: A Responsive Deep Brain Stimulator for the Treatment of Essential Tremor</title><pubDate>Mon, 04 Nov 2019 02:42:13 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160053-nct02649166-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160053-nct02649166-</guid><description><![CDATA[<p>approval_date: Mon, 31 Oct 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02649166title:</p><p>ide_number: G160053</p><p>nct_number: NCT02649166</p><p>sponsor_name: University of Florida</p><p>study_title: Closing the Loop on Tremor: A Responsive Deep Brain Stimulator for the Treatment of Essential Tremor</p>]]></description></item><item><title>G160115-NCT02908880</title><pubDate>Mon, 04 Nov 2019 02:42:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160115-nct02908880-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160115-nct02908880-</guid><description><![CDATA[<p>approval_date: Tue, 25 Oct 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/show/NCT02908880title:</p><p>ide_number: G160115</p><p>nct_number: NCT02908880</p><p>sponsor_name: Essential Medical, Inc. </p><p>study_title: Pivotal Clinical Study to Evaluate the Safety and Effectiveness of MANTA Vascular Closure Device	</p>]]></description></item><item><title>G150178-NCT02577302</title><pubDate>Mon, 04 Nov 2019 02:42:02 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150178-nct02577302-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150178-nct02577302-</guid><description><![CDATA[<p>approval_date: Wed, 19 Oct 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02577302?term=NCT02577302&rank=1title:</p><p>ide_number: G150178</p><p>nct_number: NCT02577302</p><p>sponsor_name: StimGuard, LLC. </p><p>study_title: Multi-center, Prospective, Randomized, Controlled Clinical Trial Study of Chronic Tibial Nerve Stimulation (CTNS) to Demonstrate Non-Inferiority in the Treatment of Urinary Urgency Incontinence Resulting From Refractory Overactive Bladder (OAB) With Wireless Neuromodulation Technology as Compared to Peripheral Tibial Nerve Stimulation (PTNS) - "PROTECT" Study</p>]]></description></item><item><title>Prospective, Non?randomized, Single Arm, Multicenter Clinical Evaluation of the INSPIRIS RESILIA Pulmonary Valve  (Model 11500P) for Pulmonary Valve Replacement</title><pubDate>Mon, 04 Nov 2019 02:42:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120108-nct02656290-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120108-nct02656290-</guid><description><![CDATA[<p>approval_date: Thu, 13 Oct 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02656290title:</p><p>ide_number: G120108</p><p>nct_number: NCT02656290</p><p>sponsor_name: Edwards Lifesciences </p><p>study_title: Prospective, Non‐randomized, Single Arm, Multicenter Clinical Evaluation of the INSPIRIS RESILIA Pulmonary Valve  (Model 11500P) for Pulmonary Valve Replacement</p>]]></description></item><item><title>Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC)</title><pubDate>Mon, 04 Nov 2019 02:41:56 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160089-nct02831959-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160089-nct02831959-</guid><description><![CDATA[<p>approval_date: Mon, 12 Sep 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02831959 title:</p><p>ide_number: G160089</p><p>nct_number: NCT02831959</p><p>sponsor_name: Novocure</p><p>study_title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC)</p>]]></description></item><item><title>G160015-NCT02730234</title><pubDate>Mon, 04 Nov 2019 02:41:56 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160015-nct02730234-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160015-nct02730234-</guid><description><![CDATA[<p>approval_date: Mon, 19 Sep 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02730234?term=NCT02730234&rank=1	title:</p><p>ide_number: G160015</p><p>nct_number: NCT02730234</p><p>sponsor_name: Midwest Cardiovascular Research Foundation </p><p>study_title: JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery</p>]]></description></item><item><title>G160083-NCT02863796</title><pubDate>Mon, 04 Nov 2019 02:41:56 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160083-nct02863796</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160083-nct02863796</guid><description><![CDATA[<p>approval_date: Mon, 03 Oct 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02863796	title:</p><p>ide_number: G160083</p><p>nct_number: NCT02863796</p><p>sponsor_name: Boston Biomedical Associates, LLC. </p><p>study_title: The WhiteSwell System: WhiteSwell Bloodline, WhiteSwell Console, WhiteSwell Catheter </p>]]></description></item><item><title>G150249-NCT02806570</title><pubDate>Mon, 04 Nov 2019 02:41:52 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150249-nct02806570</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150249-nct02806570</guid><description><![CDATA[<p>approval_date: Mon, 12 Sep 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02806570 	title:</p><p>ide_number: G150249</p><p>nct_number: NCT02806570</p><p>sponsor_name: Guided Delivery Systems, Inc.</p><p>study_title: GDS Accucinch Ventriculoplasty System</p>]]></description></item><item><title>G150019-NCT02397668</title><pubDate>Mon, 04 Nov 2019 02:41:51 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150019-nct02397668-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150019-nct02397668-</guid><description><![CDATA[<p>approval_date: Thu, 15 Sep 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02397668?term=NCT02397668&rank=1	title:</p><p>ide_number: G150019</p><p>nct_number: NCT02397668</p><p>sponsor_name: CorMatrix</p><p>study_title: CorMatrix ECM Tricuspid Valve Replacement Safety and Early Feasibility</p>]]></description></item><item><title>G140019-NCT02189798</title><pubDate>Mon, 04 Nov 2019 02:41:51 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140019-nct02189798-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140019-nct02189798-</guid><description><![CDATA[<p>approval_date: Mon, 12 Sep 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02189798title:</p><p>ide_number: G140019</p><p>nct_number: NCT02189798</p><p>sponsor_name: Advanced Bionics 	</p><p>study_title: Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness</p>]]></description></item><item><title>Monovisc</title><pubDate>Mon, 04 Nov 2019 02:41:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150131-nct02698865-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150131-nct02698865-</guid><description><![CDATA[<p>approval_date: Mon, 12 Sep 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02698865title:</p><p>ide_number: G150131</p><p>nct_number: NCT02698865</p><p>sponsor_name: Anika Therapeutics, Incorporated</p><p>study_title: Monovisc</p>]]></description></item><item><title>Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries</title><pubDate>Mon, 04 Nov 2019 02:41:49 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160063-nct02780869</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160063-nct02780869</guid><description><![CDATA[<p>approval_date: Wed, 10 Aug 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02780869?term=NCT02780869&rank=1title:</p><p>ide_number: G160063</p><p>nct_number: NCT02780869</p><p>sponsor_name: Biom'Up SA </p><p>study_title: Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries</p>]]></description></item><item><title>G150140-NCT02698787</title><pubDate>Mon, 04 Nov 2019 02:41:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150140-nct02698787-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150140-nct02698787-</guid><description><![CDATA[<p>approval_date: Thu, 01 Sep 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02698787	title:</p><p>ide_number: G150140</p><p>nct_number: NCT02698787</p><p>sponsor_name: Cochlear Americas</p><p>study_title: Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients	</p>]]></description></item><item><title>A Pilot, Prospective, Randomized, Controlled, Multicenter Technical Feasibility Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys Surgical Sealant</title><pubDate>Mon, 04 Nov 2019 02:41:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160120-nct02841891</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160120-nct02841891</guid><description><![CDATA[<p>approval_date: Tue, 23 Aug 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02841891 title:</p><p>ide_number: G160120</p><p>nct_number: NCT02841891</p><p>sponsor_name: Cohera Medical, Inc. </p><p>study_title: A Pilot, Prospective, Randomized, Controlled, Multicenter Technical Feasibility Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant</p>]]></description></item><item><title>Evaluation of the TULSA-PRO MRI-guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer
 </title><pubDate>Mon, 04 Nov 2019 02:41:44 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130103-nct02766543-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130103-nct02766543-</guid><description><![CDATA[<p>approval_date: Tue, 23 Aug 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02766543?term=NCT02766543&rank=1title:</p><p>ide_number: G130103</p><p>nct_number: NCT02766543</p><p>sponsor_name: Profound Medical Inc. </p><p>study_title: Evaluation of the TULSA-PRO MRI-guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer
 </p>]]></description></item><item><title>A Pilot Study to Evaluate the Safety and Efficacy of the Hypoglossal Nerve Stimulator in Adolescents and Young Adults With Down Syndrome and Obstructive Sleep Apnea</title><pubDate>Mon, 04 Nov 2019 02:41:44 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140209-nct02344108-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140209-nct02344108-</guid><description><![CDATA[<p>approval_date: Tue, 16 Aug 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02344108title:</p><p>ide_number: G140209</p><p>nct_number: NCT02344108</p><p>sponsor_name: Massachusetts Eye and Ear Infirmary </p><p>study_title: A Pilot Study to Evaluate the Safety and Efficacy of the Hypoglossal Nerve Stimulator in Adolescents and Young Adults With Down Syndrome and Obstructive Sleep Apnea</p>]]></description></item><item><title>13C-Methacetin Breath Test for the Prediction of Outcome in Acute Liver Failure</title><pubDate>Mon, 04 Nov 2019 02:41:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150226-nct02786836-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150226-nct02786836-</guid><description><![CDATA[<p>approval_date: Tue, 09 Aug 2016 12:00:00 -0400</p><p>category: B4</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02786836?term=NCT02786836&rank=1title:</p><p>ide_number: G150226</p><p>nct_number: NCT02786836</p><p>sponsor_name: William Lee</p><p>study_title: 13C-Methacetin Breath Test for the Prediction of Outcome in Acute Liver Failure</p>]]></description></item><item><title>Randomized Trial of the NeoChord DS1000 System Versus Open Surgical Repair</title><pubDate>Mon, 04 Nov 2019 02:41:41 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160067-nct02803957</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160067-nct02803957</guid><description><![CDATA[<p>approval_date: Mon, 08 Aug 2016 12:00:00 -0400</p><p>category: B2</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02803957title:</p><p>ide_number: G160067</p><p>nct_number: NCT02803957</p><p>sponsor_name: NeoChord </p><p>study_title: Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair</p>]]></description></item><item><title>Misago RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery (OSPREY ILIAC)</title><pubDate>Mon, 04 Nov 2019 02:41:39 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160035-nct02793492</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160035-nct02793492</guid><description><![CDATA[<p>approval_date: Wed, 13 Jul 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02793492title:</p><p>ide_number: G160035</p><p>nct_number: NCT02793492</p><p>sponsor_name: Terumo Medical Corporation </p><p>study_title: Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery (OSPREY ILIAC)</p>]]></description></item><item><title>Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic Persistent AF (PRECEPT)</title><pubDate>Mon, 04 Nov 2019 02:41:38 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140102-nct02817776</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140102-nct02817776</guid><description><![CDATA[<p>approval_date: Wed, 03 Aug 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02817776title:</p><p>ide_number: G140102</p><p>nct_number: NCT02817776</p><p>sponsor_name: Biosense Webster, Inc</p><p>study_title: Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic Persistent AF (PRECEPT)</p>]]></description></item><item><title>Zoll 731 Series Ventilator with Fio2 Closed-Loop Control (CLC)</title><pubDate>Mon, 04 Nov 2019 02:41:35 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150245-nct02810080</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150245-nct02810080</guid><description><![CDATA[<p>approval_date: Fri, 22 Jul 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02810080title:</p><p>ide_number: G150245</p><p>nct_number: NCT02810080</p><p>sponsor_name: Zoll Medical Corporation </p><p>study_title: Zoll 731 Series Ventilator with Fio2 Closed-Loop Control (CLC)</p>]]></description></item><item><title>State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)</title><pubDate>Mon, 04 Nov 2019 02:41:34 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150273-nct02709148</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150273-nct02709148</guid><description><![CDATA[<p>approval_date: Fri, 15 Jul 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT027091480title:</p><p>ide_number: G150273</p><p>nct_number: NCT02709148</p><p>sponsor_name: University of Minnesota - Clinical and Translational Science Institute </p><p>study_title: State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)</p>]]></description></item><item><title>G140249-NCT02657707</title><pubDate>Mon, 04 Nov 2019 02:41:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140249-nct02657707-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140249-nct02657707-</guid><description><![CDATA[<p>approval_date: Thu, 07 Jul 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02657707?term=NCT02657707&rank=1title:</p><p>ide_number: G140249</p><p>nct_number: NCT02657707</p><p>sponsor_name: Microvention-Terumo, Inc. </p><p>study_title: Pivotal Study of the MicroVention, Inc. Carotid Artery Stent System Used in Conjunction With the Nanoparasol® Embolic Protection System for the Treatment of Carotid Artery Stenosis in Patients at Elevated Risk for Adverse Events From Carotid Endarterectomy.(CONFIDENCE Trial)	</p>]]></description></item><item><title>WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures</title><pubDate>Mon, 04 Nov 2019 02:41:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150185-nct02802020</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150185-nct02802020</guid><description><![CDATA[<p>approval_date: Wed, 20 Jul 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/NCT02802020title:</p><p>ide_number: G150185</p><p>nct_number: NCT02802020</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures</p>]]></description></item><item><title>Covera Vascular Covered Stent</title><pubDate>Mon, 04 Nov 2019 02:41:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160109-nct02790606</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160109-nct02790606</guid><description><![CDATA[<p>approval_date: Fri, 22 Jul 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02790606title:</p><p>ide_number: G160109</p><p>nct_number: NCT02790606</p><p>sponsor_name: Bard Peripheral Vascular, Inc.</p><p>study_title: Covera Vascular Covered Stent</p>]]></description></item><item><title>Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)</title><pubDate>Mon, 04 Nov 2019 02:41:32 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160074-nct02787785-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160074-nct02787785-</guid><description><![CDATA[<p>approval_date: Mon, 11 Jul 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02787785title:</p><p>ide_number: G160074</p><p>nct_number: NCT02787785</p><p>sponsor_name: Boston Scientific </p><p>study_title: Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)</p>]]></description></item><item><title>G160081-NCT02780349</title><pubDate>Mon, 04 Nov 2019 02:41:30 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160081-nct02780349-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160081-nct02780349-</guid><description><![CDATA[<p>approval_date: Thu, 23 Jun 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02780349	title:</p><p>ide_number: G160081</p><p>nct_number: NCT02780349</p><p>sponsor_name: Gardia Medical, Ltd. </p><p>study_title: Evaluation of WIRION™ EPS in Lower Extremities Arteries</p>]]></description></item><item><title>G150068-NCT02145208</title><pubDate>Mon, 04 Nov 2019 02:41:30 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150068-nct02145208</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150068-nct02145208</guid><description><![CDATA[<p>approval_date: Wed, 29 Jun 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02145208title:</p><p>ide_number: G150068</p><p>nct_number: NCT02145208</p><p>sponsor_name: Medi-tate Ltd </p><p>study_title: One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (TINDTM) in Subjects With Benign Prostatic Hypertrophy (BPH).	</p>]]></description></item><item><title>G150224-NCT02724072</title><pubDate>Mon, 04 Nov 2019 02:41:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150224-nct02724072-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150224-nct02724072-</guid><description><![CDATA[<p>approval_date: Wed, 18 May 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02724072?term=NCT02724072&rank=1title:</p><p>ide_number: G150224</p><p>nct_number: NCT02724072</p><p>sponsor_name: Terumo CVS </p><p>study_title: Evaluation of the Thoraflex™ Hybrid Device for Use in the Repair or Replacement of the Ascending Aorta, Aortic Arch and Descending Aorta in an Open Surgical Procedure.	</p>]]></description></item><item><title>G160020-NCT02322840</title><pubDate>Mon, 04 Nov 2019 02:41:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160020-nct02322840-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160020-nct02322840-</guid><description><![CDATA[<p>approval_date: Thu, 23 Jun 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02322840	title:</p><p>ide_number: G160020</p><p>nct_number: NCT02322840</p><p>sponsor_name: Medtronic</p><p>study_title: Intrepid Transcatheter Mitral Valve Replacement System</p>]]></description></item><item><title>G160001-NCT02649946</title><pubDate>Mon, 04 Nov 2019 02:41:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160001-nct02649946-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160001-nct02649946-</guid><description><![CDATA[<p>approval_date: Thu, 23 Jun 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02649946	title:</p><p>ide_number: G160001</p><p>nct_number: NCT02649946</p><p>sponsor_name: Bard Peripheral Vascular </p><p>study_title: COVERA Vascular Covered Stent	</p>]]></description></item><item><title>Barostim Neo - Baroreflex Activation Therapy for Heart Failure</title><pubDate>Mon, 04 Nov 2019 02:41:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120010-nct02627196-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120010-nct02627196-</guid><description><![CDATA[<p>approval_date: Thu, 23 Jun 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02627196?term=NCT02627196&rank=1title:</p><p>ide_number: G120010</p><p>nct_number: NCT02627196</p><p>sponsor_name: CVRx</p><p>study_title: Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure</p>]]></description></item><item><title>A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation</title><pubDate>Mon, 04 Nov 2019 02:41:22 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140243-nct02775162-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140243-nct02775162-</guid><description><![CDATA[<p>approval_date: Thu, 09 Jun 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT02775162title:</p><p>ide_number: G140243</p><p>nct_number: NCT02775162</p><p>sponsor_name: OrganOx, Ltd. </p><p>study_title: A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation</p>]]></description></item><item><title>Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation</title><pubDate>Mon, 04 Nov 2019 02:41:21 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150161-nct01635998-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150161-nct01635998-</guid><description><![CDATA[<p>approval_date: Mon, 06 Jun 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT01635998?term=NCT01635998&rank=1title:</p><p>ide_number: G150161</p><p>nct_number: NCT01635998</p><p>sponsor_name: Boston Scientific, Vivek Reddy, MD </p><p>study_title: Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation</p>]]></description></item><item><title>G150254-NCT02209532</title><pubDate>Mon, 04 Nov 2019 02:41:21 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150254-nct02209532-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150254-nct02209532-</guid><description><![CDATA[<p>approval_date: Mon, 06 Jun 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02209532?term=NCT02209532&rank=1	title:</p><p>ide_number: G150254</p><p>nct_number: NCT02209532</p><p>sponsor_name: NOVADAQ</p><p>study_title: A Randomized, Prospective, Open Label, Multicenter Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping</p>]]></description></item><item><title>Caisson Transcatheter Mitral Valve Replacement (TMVR) System </title><pubDate>Mon, 04 Nov 2019 02:41:20 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160055-nct02768402-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160055-nct02768402-</guid><description><![CDATA[<p>approval_date: Mon, 06 Jun 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/results/NCT02768402title:</p><p>ide_number: G160055</p><p>nct_number: NCT02768402</p><p>sponsor_name: Caisson Interventional, LLC </p><p>study_title: Caisson Transcatheter Mitral Valve Replacement (TMVR) System </p>]]></description></item><item><title>A Pilot Study to Assess Engraftment Using CliniMACS TCR-?/? and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation in Patients With Relapsed Lymphoma</title><pubDate>Mon, 04 Nov 2019 02:41:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16328-nct02652468-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16328-nct02652468-</guid><description><![CDATA[<p>approval_date: Wed, 25 May 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02652468?term=NCT02652468&rank=1title:</p><p>ide_number: BB16328</p><p>nct_number: NCT02652468</p><p>sponsor_name: Peiman Hematti </p><p>study_title: A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation in Patients With Relapsed Lymphoma</p>]]></description></item><item><title>Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology</title><pubDate>Mon, 04 Nov 2019 02:41:18 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150047-nct02434874-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150047-nct02434874-</guid><description><![CDATA[<p>approval_date: Wed, 18 May 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02434874title:</p><p>ide_number: G150047</p><p>nct_number: NCT02434874</p><p>sponsor_name: StimGuard </p><p>study_title: Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology</p>]]></description></item><item><title>FlowTriever Pulmonary Embolectomy Clinical Study</title><pubDate>Mon, 04 Nov 2019 02:41:17 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160002-nct02692586-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g160002-nct02692586-</guid><description><![CDATA[<p>approval_date: Tue, 17 May 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02692586?term=NCT02692586&rank=1title:</p><p>ide_number: G160002</p><p>nct_number: NCT02692586</p><p>sponsor_name: Inari Medical </p><p>study_title: FlowTriever Pulmonary Embolectomy Clinical Study</p>]]></description></item><item><title>G150220-NCT02744677</title><pubDate>Mon, 04 Nov 2019 02:41:11 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150220-nct02744677-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150220-nct02744677-</guid><description><![CDATA[<p>approval_date: Wed, 04 May 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02744677title:</p><p>ide_number: G150220</p><p>nct_number: NCT02744677</p><p>sponsor_name: Edwards Lifesciences </p><p>study_title: COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV (COMPASSION S3)	</p>]]></description></item><item><title>A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction (Athena)</title><pubDate>Mon, 04 Nov 2019 02:41:09 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150173-nct02724371-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150173-nct02724371-</guid><description><![CDATA[<p>approval_date: Mon, 18 Apr 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02724371title:</p><p>ide_number: G150173</p><p>nct_number: NCT02724371</p><p>sponsor_name: Mentor Worldwide </p><p>study_title: A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction (Athena)</p>]]></description></item><item><title>A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease</title><pubDate>Mon, 04 Nov 2019 02:41:09 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150154-nct02653456-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150154-nct02653456-</guid><description><![CDATA[<p>approval_date: Wed, 04 May 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02653456?term=NCT02653456&rank=1title:</p><p>ide_number: G150154</p><p>nct_number: NCT02653456</p><p>sponsor_name: Ra Medical Systems </p><p>study_title: A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease</p>]]></description></item><item><title>Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation</title><pubDate>Mon, 04 Nov 2019 02:41:06 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150170-nct02574650</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150170-nct02574650</guid><description><![CDATA[<p>approval_date: Tue, 12 Apr 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02574650title:</p><p>ide_number: G150170</p><p>nct_number: NCT02574650</p><p>sponsor_name: Mitralign, Inc.</p><p>study_title: Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation</p>]]></description></item><item><title>Silver Nitrate-Coated Indwelling Pleural Catheter (SNCIPC) </title><pubDate>Mon, 04 Nov 2019 02:41:06 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150146-s001-nct02649894-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150146-s001-nct02649894-</guid><description><![CDATA[<p>approval_date: Wed, 13 Apr 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02649894title:</p><p>ide_number: G150146 S001 </p><p>nct_number: NCT02649894</p><p>sponsor_name: CareFusion, Inc. </p><p>study_title: Silver Nitrate-Coated Indwelling Pleural Catheter (SNCIPC) </p>]]></description></item><item><title>REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients (RESCUE)</title><pubDate>Mon, 04 Nov 2019 02:41:06 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150050-nct01747837</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150050-nct01747837</guid><description><![CDATA[<p>approval_date: Tue, 12 Apr 2016 12:00:00 -0400</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT01747837title:</p><p>ide_number: G150050</p><p>nct_number: NCT01747837</p><p>sponsor_name: Mt. Sinai</p><p>study_title: REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients (RESCUE)</p>]]></description></item><item><title>Self-Centering Guide Catheter Feasibility Study</title><pubDate>Mon, 04 Nov 2019 02:41:05 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150260-nct02639494</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150260-nct02639494</guid><description><![CDATA[<p>approval_date: Wed, 13 Apr 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02639494title:</p><p>ide_number: G150260</p><p>nct_number: NCT02639494</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: Self-Centering Guide Catheter Feasibility Study</p>]]></description></item><item><title>G140130-NCT02679430</title><pubDate>Mon, 04 Nov 2019 02:41:03 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140130-nct02679430</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140130-nct02679430</guid><description><![CDATA[<p>approval_date: Tue, 05 Apr 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url:  https://www.clinicaltrials.gov/ct2/show/NCT02679430?term=NCT02679430&rank=1title:</p><p>ide_number: G140130</p><p>nct_number: NCT02679430</p><p>sponsor_name: Sergei Sobolevsky</p><p>study_title: Analysis of Prostatic Arterial Embolization for Benign Prostatic Hyperplasia Using Embosphere Microspheres	</p>]]></description></item><item><title>A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.</title><pubDate>Mon, 04 Nov 2019 02:41:03 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130173-nct02640235</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130173-nct02640235</guid><description><![CDATA[<p>approval_date: Tue, 05 Apr 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT02640235title:</p><p>ide_number: G130173</p><p>nct_number: NCT02640235</p><p>sponsor_name: Baxter Healthcare Corporation </p><p>study_title: A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.</p>]]></description></item><item><title>G140254-NCT02314026</title><pubDate>Mon, 04 Nov 2019 02:41:00 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140254-nct02314026-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140254-nct02314026-</guid><description><![CDATA[<p>approval_date: Thu, 17 Mar 2016 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02314026	title:</p><p>ide_number: G140254</p><p>nct_number: NCT02314026</p><p>sponsor_name: Exalenz Bioscience </p><p>study_title: Clinical Study of the BreathID® System to train the algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings of Non-Alcoholic Fatty Liver Disease (NAFLD)</p>]]></description></item><item><title>G150256-NCT02687256</title><pubDate>Mon, 04 Nov 2019 02:40:54 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150256-nct02687256-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150256-nct02687256-</guid><description><![CDATA[<p>approval_date: Tue, 08 Mar 2016 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02687256?term=NCT02687256&rank=1title:</p><p>ide_number: G150256</p><p>nct_number: NCT02687256</p><p>sponsor_name: Stanford University </p><p>study_title: Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set	</p>]]></description></item><item><title>Valiant Evo US Clinical Trial</title><pubDate>Mon, 04 Nov 2019 02:40:54 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150251-nct02652949-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150251-nct02652949-</guid><description><![CDATA[<p>approval_date: Wed, 09 Mar 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url:  https://clinicaltrials.gov/ct2/show/NCT02652949?term=NCT02652949&rank=1title:</p><p>ide_number: G150251</p><p>nct_number: NCT02652949</p><p>sponsor_name: Medtronic</p><p>study_title: Valiant Evo US Clinical Trial</p>]]></description></item><item><title>G150139-NCT02626624</title><pubDate>Mon, 04 Nov 2019 02:40:52 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150139-nct02626624-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150139-nct02626624-</guid><description><![CDATA[<p>approval_date: Fri, 26 Feb 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02626624title:</p><p>ide_number: G150139</p><p>nct_number: NCT02626624</p><p>sponsor_name: Carbo-Fix Orthopedics Inc.</p><p>study_title: The CarboClear Pedicle Screw System 	</p>]]></description></item><item><title>G130270-NCT02661048</title><pubDate>Mon, 04 Nov 2019 02:40:50 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130270-nct02661048-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130270-nct02661048-</guid><description><![CDATA[<p>approval_date: Mon, 29 Feb 2016 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02661048	title:</p><p>ide_number: G130270</p><p>nct_number: NCT02661048</p><p>sponsor_name: CyberHeart Inc. </p><p>study_title: CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation</p>]]></description></item><item><title>Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men</title><pubDate>Mon, 04 Nov 2019 02:40:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150243-nct02643849</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150243-nct02643849</guid><description><![CDATA[<p>approval_date: Tue, 16 Feb 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02643849title:</p><p>ide_number: G150243</p><p>nct_number: NCT02643849</p><p>sponsor_name: SRS Medical</p><p>study_title: Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men</p>]]></description></item><item><title>The BARD® VENOVO ™ Venous Stent Study – A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease – an Assessment for Effectiveness and Safety (VERNACULAR)</title><pubDate>Mon, 04 Nov 2019 02:40:44 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150248-nct02655887</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150248-nct02655887</guid><description><![CDATA[<p>approval_date: Tue, 09 Feb 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02655887title:</p><p>ide_number: G150248</p><p>nct_number: NCT02655887</p><p>sponsor_name: Bard Peripheral Vascular</p><p>study_title: The BARD® VENOVO ™ Venous Stent Study – A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease – an Assessment for Effectiveness and Safety (VERNACULAR)</p>]]></description></item><item><title>G120029-NCT02603835</title><pubDate>Mon, 04 Nov 2019 02:40:44 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120029-nct02603835</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120029-nct02603835</guid><description><![CDATA[<p>approval_date: Thu, 04 Feb 2016 12:00:00 -0500</p><p>category: A</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02603835title:</p><p>ide_number: G120029</p><p>nct_number: NCT02603835</p><p>sponsor_name: TherOx, Inc</p><p>study_title: SSO2 therapy: IC-HOT study a multi-center evaluation of the delivery of intracoronary hyperoxemic supersaturated oxygen therapy for 60 minutes in anterior acute myocardial infarction patients with successful reperfusion (via PCI) ≤ six hours after symptom onset</p>]]></description></item><item><title>Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis</title><pubDate>Mon, 04 Nov 2019 02:40:42 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150087-nct02524834-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150087-nct02524834-</guid><description><![CDATA[<p>approval_date: Wed, 20 Jan 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02524834title:</p><p>ide_number: G150087</p><p>nct_number: NCT02524834</p><p>sponsor_name: Rodney A. White, M.D. </p><p>study_title: Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis</p>]]></description></item><item><title>Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy (COBRA-REDUCE)</title><pubDate>Mon, 04 Nov 2019 02:40:39 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130190-nct02594501</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g130190-nct02594501</guid><description><![CDATA[<p>approval_date: Mon, 25 Jan 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02594501?term=NCT02594501&rank=1title:</p><p>ide_number: G130190</p><p>nct_number: NCT02594501</p><p>sponsor_name: CeloNova BioSciences, Inc. </p><p>study_title: Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy (COBRA-REDUCE)</p>]]></description></item><item><title>REDUCE LAP-HF Randomized Trial I </title><pubDate>Mon, 04 Nov 2019 02:40:37 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150210-nct02600234</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150210-nct02600234</guid><description><![CDATA[<p>approval_date: Wed, 13 Jan 2016 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02600234title:</p><p>ide_number: G150210</p><p>nct_number: NCT02600234</p><p>sponsor_name: Corvia Medical, Inc. </p><p>study_title: REDUCE LAP-HF Randomized Trial I </p>]]></description></item><item><title>Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment</title><pubDate>Mon, 04 Nov 2019 02:40:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150034-nct02535572-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150034-nct02535572-</guid><description><![CDATA[<p>approval_date: Wed, 30 Dec 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02535572?term=NCT02535572&rank=1title:</p><p>ide_number: G150034</p><p>nct_number: NCT02535572</p><p>sponsor_name: Medical University of South Carolina </p><p>study_title: Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment</p>]]></description></item><item><title>Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee</title><pubDate>Mon, 04 Nov 2019 02:40:33 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140251-nct02436590-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140251-nct02436590-</guid><description><![CDATA[<p>approval_date: Wed, 30 Dec 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02436590?term=NCT02436590&rank=1title:</p><p>ide_number: G140251</p><p>nct_number: NCT02436590</p><p>sponsor_name: Orthofix Inc.</p><p>study_title: Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee</p>]]></description></item><item><title>G150028-NCT02586415</title><pubDate>Mon, 04 Nov 2019 02:40:32 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150028-nct02586415-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150028-nct02586415-</guid><description><![CDATA[<p>approval_date: Fri, 04 Dec 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02586415?term=NCT02586415&rank=1title:</p><p>ide_number: G150028</p><p>nct_number: NCT02586415</p><p>sponsor_name: Gregory W Albers </p><p>study_title: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3	</p>]]></description></item><item><title>EVOLVE Short DAPT Study </title><pubDate>Mon, 04 Nov 2019 02:40:32 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150194-nct02605447-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150194-nct02605447-</guid><description><![CDATA[<p>approval_date: Fri, 18 Dec 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02605447title:</p><p>ide_number: G150194</p><p>nct_number: NCT02605447</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: EVOLVE Short DAPT Study </p>]]></description></item><item><title>Clinical Evaluation of a Vascular Anastomotic Connector System for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis </title><pubDate>Mon, 04 Nov 2019 02:40:30 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140221-nct02532621-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140221-nct02532621-</guid><description><![CDATA[<p>approval_date: Tue, 15 Dec 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02532621title:</p><p>ide_number: G140221</p><p>nct_number: NCT02532621</p><p>sponsor_name: Phraxis, Inc.</p><p>study_title: Clinical Evaluation of a Vascular Anastomotic Connector System for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis </p>]]></description></item><item><title>Prostate Artery Embolization Safety and Efficacy: A Pilot Study</title><pubDate>Mon, 04 Nov 2019 02:40:26 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150021-nct02592473</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150021-nct02592473</guid><description><![CDATA[<p>approval_date: Tue, 24 Nov 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02592473title:</p><p>ide_number: G150021</p><p>nct_number: NCT02592473</p><p>sponsor_name: University of Virginia </p><p>study_title: Prostate Artery Embolization Safety and Efficacy: A Pilot Study</p>]]></description></item><item><title>Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System (CLIRST III)</title><pubDate>Mon, 04 Nov 2019 02:40:25 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16266-nct02538978</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16266-nct02538978</guid><description><![CDATA[<p>approval_date: Tue, 24 Nov 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02538978?term=NCT02538978&rank=1title:</p><p>ide_number: BB16266</p><p>nct_number: NCT02538978</p><p>sponsor_name: Cesca Therapeutics, Inc. </p><p>study_title: Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System (CLIRST III)</p>]]></description></item><item><title>Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)</title><pubDate>Mon, 04 Nov 2019 02:40:23 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16057-nct02438306</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb16057-nct02438306</guid><description><![CDATA[<p>approval_date: Wed, 18 Nov 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02438306title:</p><p>ide_number: BB16057</p><p>nct_number: NCT02438306</p><p>sponsor_name: BioCardia, Inc. </p><p>study_title: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)</p>]]></description></item><item><title>CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery</title><pubDate>Mon, 04 Nov 2019 02:40:22 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140256-nct02566525</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140256-nct02566525</guid><description><![CDATA[<p>approval_date: Thu, 12 Nov 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02566525title:</p><p>ide_number: G140256</p><p>nct_number: NCT02566525</p><p>sponsor_name: CytoSorbents, Inc </p><p>study_title: CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery</p>]]></description></item><item><title>Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?</title><pubDate>Mon, 04 Nov 2019 02:40:21 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150054-nct02566616</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150054-nct02566616</guid><description><![CDATA[<p>approval_date: Tue, 10 Nov 2015 12:00:00 -0500</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02566616?term=NCT02566616&rank=1title:</p><p>ide_number: G150054</p><p>nct_number: NCT02566616</p><p>sponsor_name: University of Chicago </p><p>study_title: Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?</p>]]></description></item><item><title>A Randomized Trial Comparing the ELUVIA Drug-eluting Stent Versus Zilver PTX Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries</title><pubDate>Mon, 04 Nov 2019 02:40:11 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150171-nct02574481</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150171-nct02574481</guid><description><![CDATA[<p>approval_date: Wed, 28 Oct 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/show/NCT02574481title:</p><p>ide_number: G150171</p><p>nct_number: NCT02574481</p><p>sponsor_name: Boston Scientific Corporation</p><p>study_title: A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries</p>]]></description></item><item><title>A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions</title><pubDate>Mon, 04 Nov 2019 02:40:09 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150032-nct02477579</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150032-nct02477579</guid><description><![CDATA[<p>approval_date: Wed, 23 Sep 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02477579title:</p><p>ide_number: G150032</p><p>nct_number: NCT02477579</p><p>sponsor_name: Nitiloop Ltd. </p><p>study_title: A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions</p>]]></description></item><item><title>Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads		</title><pubDate>Mon, 04 Nov 2019 02:40:08 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150147-nct02290028-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150147-nct02290028-</guid><description><![CDATA[<p>approval_date: Mon, 21 Sep 2015 01:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02290028?term=NCT02290028&rank=1title:</p><p>ide_number: G150147</p><p>nct_number: NCT02290028</p><p>sponsor_name: Biotronik SE &#x26; Co. KG </p><p>study_title: Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads		</p>]]></description></item><item><title>The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)</title><pubDate>Mon, 04 Nov 2019 02:40:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150052-nct02483988-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150052-nct02483988-</guid><description><![CDATA[<p>approval_date: Mon, 28 Sep 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02483988?term=NCT02483988&rank=1title:</p><p>ide_number: G150052</p><p>nct_number: NCT02483988</p><p>sponsor_name: Active Implants </p><p>study_title: The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)</p>]]></description></item><item><title>aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation</title><pubDate>Mon, 04 Nov 2019 02:40:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150107-nct02513797-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150107-nct02513797-</guid><description><![CDATA[<p>approval_date: Tue, 29 Sep 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02513797?term=NCT02513797&rank=1title:</p><p>ide_number: G150107</p><p>nct_number: NCT02513797</p><p>sponsor_name: SentreHEART, Inc. </p><p>study_title: aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation</p>]]></description></item><item><title>A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an Investigational Device Exemption (IDE) Study</title><pubDate>Mon, 04 Nov 2019 02:40:04 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150175-nct02548455</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150175-nct02548455</guid><description><![CDATA[<p>approval_date: Tue, 29 Sep 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02548455?term=NCT02548455&rank=1title:</p><p>ide_number: G150175</p><p>nct_number: NCT02548455</p><p>sponsor_name: St. Jude Medical </p><p>study_title: A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an Investigational Device Exemption (IDE) Study</p>]]></description></item><item><title>Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System in Femoropoliteal Arteries (TOBA II)</title><pubDate>Mon, 04 Nov 2019 02:40:03 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150029-nct02522884-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150029-nct02522884-</guid><description><![CDATA[<p>approval_date: Wed, 23 Sep 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02522884?term=NCT02522884&rank=1title:</p><p>ide_number: G150029</p><p>nct_number: NCT02522884</p><p>sponsor_name: Intact Vascular </p><p>study_title: Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries (TOBA II)</p>]]></description></item><item><title>G140202-NCT02525783</title><pubDate>Mon, 04 Nov 2019 02:40:01 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140202-nct02525783-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140202-nct02525783-</guid><description><![CDATA[<p>approval_date: Wed, 23 Sep 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02525783title:</p><p>ide_number: G140202</p><p>nct_number: NCT02525783</p><p>sponsor_name: Tornier, Inc.</p><p>study_title: Pyrocarbon IDE Study 		</p>]]></description></item><item><title>Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)</title><pubDate>Mon, 04 Nov 2019 02:39:54 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150079-nct02468778-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150079-nct02468778-</guid><description><![CDATA[<p>approval_date: Mon, 17 Aug 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02468778title:</p><p>ide_number: G150079</p><p>nct_number: NCT02468778</p><p>sponsor_name: Thoratec Corporation </p><p>study_title: Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)</p>]]></description></item><item><title>Analysis of Revascularization in Ischemic Stroke with EmboTrap (ARISE II).  </title><pubDate>Mon, 04 Nov 2019 02:39:54 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140253-nct02488915-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140253-nct02488915-</guid><description><![CDATA[<p>approval_date: Mon, 17 Aug 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02488915title:</p><p>ide_number: G140253</p><p>nct_number: NCT02488915</p><p>sponsor_name: Neuravi® Inc.,</p><p>study_title: Analysis of Revascularization in Ischemic Stroke with EmboTrap® (ARISE II).  </p>]]></description></item><item><title>Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms</title><pubDate>Mon, 04 Nov 2019 02:39:48 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150057-nct02489539</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150057-nct02489539</guid><description><![CDATA[<p>approval_date: Wed, 05 Aug 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02489539title:</p><p>ide_number: G150057</p><p>nct_number: NCT02489539</p><p>sponsor_name: W.L.Gore &#x26; Associates </p><p>study_title: Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms</p>]]></description></item><item><title>Medtronic Resolute Onyx Core (2.25 mm - 4.0 mm) Clinical Study</title><pubDate>Mon, 04 Nov 2019 02:39:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140178-nct02419521</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140178-nct02419521</guid><description><![CDATA[<p>approval_date: Thu, 02 Jul 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/results/NCT02419521title:</p><p>ide_number: G140178</p><p>nct_number: NCT02419521</p><p>sponsor_name: Medtronic Vascular</p><p>study_title: Medtronic Resolute Onyx Core (2.25 mm - 4.0 mm) Clinical Study</p>]]></description></item><item><title>G140178-NCT02412501</title><pubDate>Mon, 04 Nov 2019 02:39:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140178-nct02412501</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140178-nct02412501</guid><description><![CDATA[<p>approval_date: Thu, 14 May 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://www.clinicaltrials.gov/ct2/show/NCT02412501title:</p><p>ide_number: G140178</p><p>nct_number: NCT02412501</p><p>sponsor_name: Medtronic Vascular </p><p>study_title: Resolute Onyx 2.0 mm Clinical Study - A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent	</p>]]></description></item><item><title>Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (BIOFLOW-V)</title><pubDate>Mon, 04 Nov 2019 02:39:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140078-nct02389946</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140078-nct02389946</guid><description><![CDATA[<p>approval_date: Fri, 17 Apr 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02389946title:</p><p>ide_number: G140078 </p><p>nct_number: NCT02389946</p><p>sponsor_name: Biotronik, Inc. </p><p>study_title: Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (BIOFLOW-V)</p>]]></description></item><item><title>Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System</title><pubDate>Mon, 04 Nov 2019 02:39:47 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150006-nct02340585</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150006-nct02340585</guid><description><![CDATA[<p>approval_date: Tue, 14 Apr 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02340585title:</p><p>ide_number: G150006</p><p>nct_number: NCT02340585 </p><p>sponsor_name: STRYKER</p><p>study_title: Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System</p>]]></description></item><item><title>Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens</title><pubDate>Mon, 04 Nov 2019 02:39:46 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140134-nct02487160-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140134-nct02487160-</guid><description><![CDATA[<p>approval_date: Tue, 28 Jul 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02487160title:</p><p>ide_number: G140134</p><p>nct_number: NCT02487160</p><p>sponsor_name: Lenstec Incorporated </p><p>study_title: Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens</p>]]></description></item><item><title>Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams</title><pubDate>Mon, 04 Nov 2019 02:39:46 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140213-nct-02396420-</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140213-nct-02396420-</guid><description><![CDATA[<p>approval_date: Tue, 28 Jul 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02396420?term=NCT02396420&rank=1title:</p><p>ide_number: 
G140213</p><p>nct_number: NCT02396420</p><p>sponsor_name: South Florida Medical Imaging, PA </p><p>study_title: Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams</p>]]></description></item><item><title>Endurant Evo US Clinical Trial </title><pubDate>Mon, 04 Nov 2019 02:39:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150024-nct02393716</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150024-nct02393716</guid><description><![CDATA[<p>approval_date: Fri, 17 Apr 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02393716title:</p><p>ide_number: G150024</p><p>nct_number: NCT02393716</p><p>sponsor_name: Medtronic Endovascular </p><p>study_title: Endurant Evo US Clinical Trial </p>]]></description></item><item><title>The Asahi Intecc PTCA Chronic Total Occlusion Study</title><pubDate>Mon, 04 Nov 2019 02:39:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150007-nct02379923</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150007-nct02379923</guid><description><![CDATA[<p>approval_date: Thu, 04 Jun 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02379923title:</p><p>ide_number: G150007 </p><p>nct_number: NCT02379923</p><p>sponsor_name: Asahi Intecc USA Inc</p><p>study_title: The Asahi Intecc PTCA Chronic Total Occlusion Study</p>]]></description></item><item><title>Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae</title><pubDate>Mon, 04 Nov 2019 02:39:45 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150067-nct02440022</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g150067-nct02440022</guid><description><![CDATA[<p>approval_date: Wed, 17 Jun 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02440022title:</p><p>ide_number: G150067 </p><p>nct_number: NCT02440022</p><p>sponsor_name: C. R. Bard </p><p>study_title: Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae</p>]]></description></item><item><title>Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System (MIMICS-2)</title><pubDate>Mon, 04 Nov 2019 02:39:43 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140182-nct02400905</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140182-nct02400905</guid><description><![CDATA[<p>approval_date: Mon, 29 Jun 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/NCT02400905title:</p><p>ide_number: G140182</p><p>nct_number: NCT02400905</p><p>sponsor_name: Veryan Medical Ltd. </p><p>study_title: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System (MIMICS-2)</p>]]></description></item><item><title>G140118-NCT02073565</title><pubDate>Mon, 04 Nov 2019 02:39:43 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140118-nct02073565</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140118-nct02073565</guid><description><![CDATA[<p>approval_date: Wed, 01 Apr 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02073565title:</p><p>ide_number: G140118</p><p>nct_number: NCT02073565</p><p>sponsor_name: OrbusNeich</p><p>study_title: HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt	</p>]]></description></item><item><title>A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components</title><pubDate>Mon, 04 Nov 2019 02:39:43 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb6200-nct02305732</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/bb6200-nct02305732</guid><description><![CDATA[<p>approval_date: Tue, 05 May 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02305732title:</p><p>ide_number: BB6200 </p><p>nct_number: NCT0230573</p><p>sponsor_name: Cerus Corporation</p><p>study_title: A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components</p>]]></description></item><item><title>Zenith p-Branch Pivotal Study</title><pubDate>Mon, 04 Nov 2019 02:39:43 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120136s007-nct02396199</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g120136s007-nct02396199</guid><description><![CDATA[<p>approval_date: Wed, 06 May 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02396199title:</p><p>ide_number: G120136</p><p>nct_number: NCT02396199</p><p>sponsor_name: Cook Incorporated </p><p>study_title: Zenith® p-Branch® Pivotal Study</p>]]></description></item><item><title>Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI With Crux VCF System</title><pubDate>Mon, 04 Nov 2019 02:39:42 -0500</pubDate><link>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140194-nct02394912</link><guid>https://www.cms.gov//medicare/coverage/ide/approved-ide-studies-items/g140194-nct02394912</guid><description><![CDATA[<p>approval_date: Wed, 01 Apr 2015 12:00:00 -0400</p><p>category: B</p><p>clinical_study_link: url: https://clinicaltrials.gov/ct2/show/NCT02394912?term=NCT02394912&rank=1title:</p><p>ide_number: G140194</p><p>nct_number: NCT02394912</p><p>sponsor_name: Volcano Corporation </p><p>study_title: Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System</p>]]></description></item></channel></rss>