1417 lines
127 KiB
Text
1417 lines
127 KiB
Text
<!DOCTYPE html>
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<html lang="en" dir="ltr">
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<head>
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<meta charset="utf-8" />
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<meta name="description" content="The following provide information on materials (devices, software, surgical tools, etc.) and support that each of the indicated different companies are willing to make available for applications as part of the BRAIN Public-Private Partnership Program. NIH does not endorse any of the companies listed and has not verified the data or claims that the companies represent in these documents." />
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<link rel="canonical" href="http://www.braininitiative.nih.gov/research/neural-recording-and-modulation/public-private-partnerships-program/devices-support" />
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<title>Devices & Support Specific Manufacturers | BRAIN Initiative</title>
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</div>
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<div class="usa-header-text d-sm-inline-block">An official website of the United States government</div>
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<button class="usa-banner-link btn-link collapsed" type="button" data-toggle="collapse" data-target="#usaBodyWrapper" aria-expanded="true" aria-controls="usaBodyWrapper">
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</div>
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<div class="usa-media-block__body col">
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<div class="font-weight-bold">Official websites use .gov </div>
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A
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<span class="font-weight-bold">.gov</span>
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website belongs to an official government organization in the United States.
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<div class="row">
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<div class="usa-media-block__img col-auto">
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<img src="/themes/contrib/ninds_base_theme_barrio/assets/images/theme/icon-https.svg" role="img" alt="" aria-hidden="true">
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<div class="font-weight-bold">Secure .gov websites use HTTPS</div>
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<span class="font-weight-bold">)</span>
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or
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<span class="font-weight-bold">https://</span>
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means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.
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srcset="/themes/custom/brain_bootstrap/assets/images/layout/header/brain_logo.webp 1500w, /themes/custom/brain_bootstrap/assets/images/layout/header/mobile_brain_logo.webp 600w"
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sizes="(max-width: 992px) 100px, 800px"
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alt="BRAIN Initiative - Home" />
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</a>
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<img class="float-right d-print-block d-none" alt role="presentation" src="data:image/png;base64,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"/>
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<div class="mobile-icons-container d-lg-none">
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<button class="navbar-toggler" type="button" data-toggle="collapse" data-target="#collapseSearch" aria-expanded="false" aria-controls="collapseSearch">
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<i aria-hidden="true" class="fas fa-search" title="Search"></i>
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<span class="sr-only">Search</span>
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</button>
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<button class="navbar-toggler" type="button" data-toggle="collapse" data-target="#CollapsingNavbar" aria-controls="CollapsingNavbar" aria-expanded="false" aria-label="Toggle navigation">
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<i aria-hidden="true" class="fas fa-bars mobile-menu-button" title="Menu"></i><span class="sr-only">Menu</span>
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</button>
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<div class="d-none d-lg-inline-block site-search navbar-form">
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<section class="region region-top-header-form">
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<div class="views-exposed-form block block-views block-views-exposed-filter-blocksite-search-page-1" data-drupal-selector="views-exposed-form-site-search-page-1" id="block-brain-bootstrap-exposedformsite-searchpage-1">
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<div class="content">
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<form block="brain_bootstrap_exposedformsite_searchpage_1" action="/search" method="get" id="views-exposed-form-site-search-page-1" accept-charset="UTF-8" class="form-inline">
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<div class="form-group">
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<fieldset class="js-form-item js-form-type-search-api-autocomplete form-type-search-api-autocomplete js-form-item-search-api-fulltext form-item-search-api-fulltext form-group">
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<label for="edit-search-api-fulltext">Search</label>
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<input placeholder="Search" data-drupal-selector="edit-search-api-fulltext" data-search-api-autocomplete-search="site_search" class="form-autocomplete form-control" data-autocomplete-path="/search_api_autocomplete/site_search?display=page_1&&filter=search_api_fulltext" type="text" id="edit-search-api-fulltext" name="search_api_fulltext" value="" size="30" maxlength="128" />
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</fieldset>
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</div>
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<div class="form-group site-search-submit ">
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<button type="submit" class="btn btn-search" aria-label="Submit Search"><i class="fas fa-search"></i></button>
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</div>
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</form>
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</section>
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</div>
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</nav>
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<div class="navbar navbar-expand-lg" id="navbar-main">
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<div class="container-fluid">
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<div class="mobile-search-form site-search collapse" id="collapseSearch">
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<section class="region region-header-form">
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>The following provide information on materials (devices, software, surgical tools, etc.) and support that each of the indicated different companies are willing to make available for applications as part of the <a href="/glossary?title=BRAIN" class="glossary-tooltip" data-toggle="tooltip" title="The Brain Research through Advancing Innovative Neurotechnologies Initiative aims to accelerate the development and application of innovate technologies to produce a new, dynamic picture of the brain.">BRAIN</a> Public-Private Partnership Program. </p>
|
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<p><a href="/glossary?title=NIH" class="glossary-tooltip" data-toggle="tooltip" title="National Institutes of Health - A Federal agency whose mission is to improve the health of the people of the United States. NIH is a part of the Public Health Service, which is part of the U.S. Department of Health and Human Services. ">NIH</a> does not endorse any of the companies listed and has not verified the data or claims that the companies represent in these documents.</p>
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<table class="data-table-formatter responsive-enabled table table-bordered" style="width: 100%" data-striping="1">
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<caption>This is a preview of the Data Table. Only the first three rows are displayed.</caption>
|
||
|
||
|
||
<thead class>
|
||
<tr>
|
||
<th id="table-index-company"><span>Company</span></th>
|
||
<th id="table-index-product"><span>Product</span></th>
|
||
<th id="table-index-prior-use-in-humans"><span>Prior use in Humans</span></th>
|
||
<th id="table-index-application-/-original-indication"><span>Application / Original Indication</span></th>
|
||
<th id="table-index-regulatory-status"><span>Regulatory Status</span></th>
|
||
<th id="table-index-accessories-"><span>Accessories </span></th>
|
||
<th id="table-index-device-information-&-company-support"><span>Device Information & Company Support</span></th>
|
||
<th id="table-index-product-page-link"><span>Product Page Link</span></th>
|
||
<th id="table-index-company-contact-"><span>Company Contact </span></th>
|
||
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|
||
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|
||
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|
||
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|
||
<th scope="row" id="row-index-1" headers="table-index-company">Abbott</th>
|
||
<td headers="table-index-product row-index-1">Infinity DBS</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-1">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-1">DBS of the Subthalamic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson's disease that are not adequately controlled by medications, and unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients</td>
|
||
<td headers="table-index-regulatory-status row-index-1">PMA, CE Marked</td>
|
||
<td headers="table-index-accessories- row-index-1">Clinician Programmer, Patient Controller, Burr Hole Cover, Infinity and Traditional Leads, Lead Extension</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-1"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/infinity_dbs_device_information_508c.pdf">Infinity DBS Device Information (PDF- 305 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-1"><a href="https://www.neuromodulation.abbott/us/en/hcp/products/dbs-movement-disorders/st-jude-medical-infinity-dbs-system.html">Infinity DBS</a></td>
|
||
<td headers="table-index-company-contact- row-index-1"><a href="mailto:binith.cheeran@abbott.com">Binith Cheeran</a>, Director of Medical Affairs </td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-2" headers="table-index-company">Abbott</th>
|
||
<td headers="table-index-product row-index-2">Proclaim SCS</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-2">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-2">SCS as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain</td>
|
||
<td headers="table-index-regulatory-status row-index-2">PMA, CE Marked</td>
|
||
<td headers="table-index-accessories- row-index-2">Clinician Programmer, Patient Controller, Percutaneous and Paddle Leads</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-2"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/proclaim_elite_scs_device_information_508c.pdf">Proclaim Elite SCS Device Information (PDF- 365 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-2"><a href="https://www.neuromodulation.abbott/us/en/hcp/products/spinal-column-stimulation-for-chronic-pain/proclaim-elite-scs-system.html">Proclaim Elite SCS</a></td>
|
||
<td headers="table-index-company-contact- row-index-2"><a href="mailto:binith.cheeran@abbott.com">Binith Cheeran</a>, Director of Medical Affairs </td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-3" headers="table-index-company">Abbott</th>
|
||
<td headers="table-index-product row-index-3">Prodigy SCS</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-3">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-3">SCS as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain</td>
|
||
<td headers="table-index-regulatory-status row-index-3">PMA, CE Marked</td>
|
||
<td headers="table-index-accessories- row-index-3">Clinician Programmer, Patient Controller, Percutaneous and Paddle Leads</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-3"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/prodigy_mri_scs_device_information_508c.pdf">Prodigy MRI SCS Device Information (PDF- 311 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-3"><a href="https://www.neuromodulation.abbott/us/en/hcp/products/spinal-column-stimulation-for-chronic-pain/prodigy-mri-scs-system.html">Prodigy MRI</a></td>
|
||
<td headers="table-index-company-contact- row-index-3"><a href="mailto:binith.cheeran@abbott.com">Binith Cheeran</a>, Director of Medical Affairs </td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-4" headers="table-index-company">Abbott</th>
|
||
<td headers="table-index-product row-index-4">Proclaim DRG</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-4">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-4">Indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II</td>
|
||
<td headers="table-index-regulatory-status row-index-4">PMA, CE Marked</td>
|
||
<td headers="table-index-accessories- row-index-4">Clinician Programmer, Patient Controller, Percutaneous Leads </td>
|
||
<td headers="table-index-device-information-&-company-support row-index-4"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/proclaim_drg_device_information_508c.pdf">Proclaim DRG Device Information (PDF- 295 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-4"><a href="https://www.cardiovascular.abbott/us/en/home.html">Proclaim DRG</a></td>
|
||
<td headers="table-index-company-contact- row-index-4"><a href="mailto:binith.cheeran@abbott.com">Binith Cheeran</a>, Director of Medical Affairs </td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-5" headers="table-index-company">Blackrock Microsystems</th>
|
||
<td headers="table-index-product row-index-5">NeuroPort Electrode Array</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-5">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-5">Recording and monitoring of intracortical activity</td>
|
||
<td headers="table-index-regulatory-status row-index-5">510(k) (<30 days), IDE/IRB (>30 days)</td>
|
||
<td headers="table-index-accessories- row-index-5">Engineering Expertise, Regulatory Assistance, Data Repository</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-5"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/neuroport_electrode_array_device_information_508c.pdf">NeuroPort Electrode Array Device Information (PDF- 1.2 MB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-5"><a href="https://blackrockmicro.com/neuroport-array/">Neuroport Electrode Array</a></td>
|
||
<td headers="table-index-company-contact- row-index-5"><a href="mailto:florian.solzbacher@utah.edu">Florian Solzbacher</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-6" headers="table-index-company">Blackrock Microsystems</th>
|
||
<td headers="table-index-product row-index-6">Utah Slanted Electrode Array</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-6">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-6">Intrafascicular microelectrode array for peripheral nerve applications</td>
|
||
<td headers="table-index-regulatory-status row-index-6">IDE</td>
|
||
<td headers="table-index-accessories- row-index-6">Engineering Expertise, Regulatory Assistance, Data Repository</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-6"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/utah_slanted_electrode_array_device_information_508c.pdf">Utah Slanted Electrode Array Device Information (PDF- 455 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-6"><a href="https://blackrockmicro.com/utah-slant-array/">Utah Slanted Electrode Array</a></td>
|
||
<td headers="table-index-company-contact- row-index-6"><a href="mailto:florian.solzbacher@utah.edu">Florian Solzbacher</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-7" headers="table-index-company">Blackrock Microsystems</th>
|
||
<td headers="table-index-product row-index-7">NeuroPort Biopotential Signal Processing System</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-7">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-7">Supports recording and display of local field potentials and extra cellular spikes from the brain Real-time data acquisition and processing system for up to 512 channels</td>
|
||
<td headers="table-index-regulatory-status row-index-7">510(k)</td>
|
||
<td headers="table-index-accessories- row-index-7">Engineering Expertise, Regulatory Assistance, Data Repository</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-7"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/neuroport_biopotential_signal_processing_system_device_information_508c.pdf">NeuroPort Biopotential Signal Processing System Device Information (PDF- 163 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-7"><a href="https://blackrockmicro.com/wp-content/ifu/LB-0175_NeuroPort_Biopotential_Signal_Processing_System_Users_Manual.pdf">NeuroPort Biopotential Signal Processing System</a></td>
|
||
<td headers="table-index-company-contact- row-index-7"><a href="mailto:florian.solzbacher@utah.edu">Florian Solzbacher</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-8" headers="table-index-company">Blackrock Microsystems</th>
|
||
<td headers="table-index-product row-index-8">Cervello Elite</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-8">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-8">128 or 256 channel combined video EEG and microelectrode data acquisition system</td>
|
||
<td headers="table-index-regulatory-status row-index-8">510(k)</td>
|
||
<td headers="table-index-accessories- row-index-8">Engineering Expertise, Regulatory Assistance, Data Repository</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-8"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/cervello_elite_device_information_508c.pdf">Cervello Elite Device Information (PDF- 157 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-8">Not available</td>
|
||
<td headers="table-index-company-contact- row-index-8"><a href="mailto:florian.solzbacher@utah.edu">Florian Solzbacher</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-9" headers="table-index-company">Blackrock Microsystems</th>
|
||
<td headers="table-index-product row-index-9">CerePlex I</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-9">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-9">128 channel fully implantable integrated electrode and amplifier system</td>
|
||
<td headers="table-index-regulatory-status row-index-9">IDE/IRB</td>
|
||
<td headers="table-index-accessories- row-index-9">Engineering Expertise, Regulatory Assistance, Data Repository</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-9"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/cereplex_i_device_information_508c.pdf">CerePlex I Device Information (PDF- 232 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-9">Not available</td>
|
||
<td headers="table-index-company-contact- row-index-9"><a href="mailto:florian.solzbacher@utah.edu">Florian Solzbacher</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-10" headers="table-index-company">Blackrock Microsystems</th>
|
||
<td headers="table-index-product row-index-10">CereStim</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-10">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-10">96 channel stimulator for micro and macro electrodes</td>
|
||
<td headers="table-index-regulatory-status row-index-10">IDE/IRB</td>
|
||
<td headers="table-index-accessories- row-index-10">Engineering Expertise, Regulatory Assistance, Data Repository</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-10"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/cerestim_device_information_508c.pdf">CereStim Device Information (PDF- 173 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-10"><a href="https://blackrockmicro.com/neuroscience-research-products/ephys-stimulation-systems/cerestim-96-neurostimulation-system/">CereStim Device</a></td>
|
||
<td headers="table-index-company-contact- row-index-10"><a href="mailto:florian.solzbacher@utah.edu">Florian Solzbacher</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-11" headers="table-index-company">Blackrock Microsystems</th>
|
||
<td headers="table-index-product row-index-11">Electrode Inserter System</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-11">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-11">Pneumatic electrode array insertion system</td>
|
||
<td headers="table-index-regulatory-status row-index-11">510(k)</td>
|
||
<td headers="table-index-accessories- row-index-11">Engineering Expertise, Regulatory Assistance, Data Repository</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-11"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/electrode_inserter_system_device_information_508c.pdf">Electrode Inserter System Device Information (PDF- 316 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-11"><a href="https://www.braininitiative.nih.gov/sites/default/files/pdfs/electrode_inserter_system_device_information_508c.pdf">Electrode Inserter System</a></td>
|
||
<td headers="table-index-company-contact- row-index-11"><a href="mailto:florian.solzbacher@utah.edu">Florian Solzbacher</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-12" headers="table-index-company">Blackrock Microsystems</th>
|
||
<td headers="table-index-product row-index-12">Splitter Box</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-12">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-12">Headstage allowing Blackrock NeuroPort Biopotential Signal Processing System to share electrode signals with 3rd party acquisition systems</td>
|
||
<td headers="table-index-regulatory-status row-index-12">510(k)</td>
|
||
<td headers="table-index-accessories- row-index-12">Contact Company Representative </td>
|
||
<td headers="table-index-device-information-&-company-support row-index-12"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/splitter_box_device_information_508c.pdf">Splitter Box Device Information (PDF- 271 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-12"><a href="https://blackrockmicro.com/wp-content/uploads/2016/01/LB-0345-3.00-64-Channel-Splitter-Box-IFU.pdf">Splitter Box</a></td>
|
||
<td headers="table-index-company-contact- row-index-12"><a href="mailto:florian.solzbacher@utah.edu">Florian Solzbacher</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-13" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-13">Vercise Deep Brain Stimulation System</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-13">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-13">DBS for Parkinson's Disease</td>
|
||
<td headers="table-index-regulatory-status row-index-13"> PMA; CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-13"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/deep_brain_stimulation_accessories_508c.pdf">Deep Brain Stimulation Accessories (PDF- 444 KB)</a></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-13"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/vercise_deep_brain_stimulation_system_information_508c.pdf">Vercise Deep Brain Stimulation System Information (PDF- 340 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-13"><a href="http://www.bostonscientific.com/en-EU/products/deep-brain-stimulation-systems.html">Vercise Deep Brain Stimulation System</a></td>
|
||
<td headers="table-index-company-contact- row-index-13"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-14" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-14">Precision Spectra; Precision Wavewriter; Precision Novio; Precision Montage Spinal Cord Stimulator System</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-14">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-14">SCS for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain</td>
|
||
<td headers="table-index-regulatory-status row-index-14">PMA; CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-14"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/spinal_cord_stimulation_accessories_508c.pdf">Spinal Cord Stimulation Accessories (PDF- 314 KB)</a></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-14"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/precision_spinal_cord_stimulation_system_information_508c.pdf">Precision Spinal Cord Stimulation System Information (PDF- 455 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-14"><a href="https://www.bostonscientific.com/en-US/products/spinal-cord-stimulator-systems.html">Precision Spinal Cord Stimulation System</a></td>
|
||
<td headers="table-index-company-contact- row-index-14"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-15" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-15">VERCISE Genus Deep Brain Stimulation System</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-15">Y</td>
|
||
<td headers="table-index-application-/-original-indication row-index-15">The Boston Scientific DBS System is indicated for use in the following: Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinsons disease (PD) that are not adequately controlled with medication. Bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa-responsive Parkinsons disease (PD) that are not adequately controlled with medication.Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.</td>
|
||
<td headers="table-index-regulatory-status row-index-15">PMA; CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-15"></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-15"><a href="https://acrobat.adobe.com/link/review?uri=urn:aaid:scds:US:4109f41e-fec5-3ee7-aa03-87ebf24fcaae">Vercise Genus System</a></td>
|
||
<td headers="table-index-product-page-link row-index-15"><a href="https://www.bostonscientific.com/en-US/products/deep-brain-stimulation-systems/vercise-genus-dbs-system.html">Vercise Genus Deep Brain Stimulation (DBS) System</a></td>
|
||
<td headers="table-index-company-contact- row-index-15"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-16" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-16">VERCISE Gevia Deep Brain Stimulation System</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-16">Y</td>
|
||
<td headers="table-index-application-/-original-indication row-index-16">Same as Vercise Genus System</td>
|
||
<td headers="table-index-regulatory-status row-index-16">PMA; CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-16"></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-16"><a href="https://acrobat.adobe.com/link/review?uri=urn:aaid:scds:US:059246b2-84e0-3ed4-adc4-eee099d53387">Vercise Gevia and Vercise PC System</a></td>
|
||
<td headers="table-index-product-page-link row-index-16"><a href="https://www.bostonscientific.com/en-US/products/deep-brain-stimulation-systems/vercise-gevia-tm-dbs-system.html">Vercise Gevia DBS System</a></td>
|
||
<td headers="table-index-company-contact- row-index-16"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-17" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-17">VERCISE PC Deep Brain Stimulation system</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-17">Y</td>
|
||
<td headers="table-index-application-/-original-indication row-index-17">Same as Vercise Genus System</td>
|
||
<td headers="table-index-regulatory-status row-index-17">PMA; CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-17"></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-17"><a href="https://acrobat.adobe.com/link/review?uri=urn:aaid:scds:US:059246b2-84e0-3ed4-adc4-eee099d53387">Vercise Gevia and Vercise PC System</a></td>
|
||
<td headers="table-index-product-page-link row-index-17"><a href="https://www.bostonscientific.com/en-US/products/deep-brain-stimulation-systems/vercise-tm-pc-dbs-system.html">Vercise PC DBS System</a></td>
|
||
<td headers="table-index-company-contact- row-index-17"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-18" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-18">GUIDE XT DBS Software</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-18">Y</td>
|
||
<td headers="table-index-application-/-original-indication row-index-18">The GUIDE XT System is intended to display medical images and simulate stimulation output. It depicts the lead position in the brain anatomical images based on patients computerized tomography (CT) results and simulates the stimulation field with the parameter settings. It also includes functions for image manipulation and 3D visualization.</td>
|
||
<td headers="table-index-regulatory-status row-index-18">CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-18"><a href="https://acrobat.adobe.com/link/review?uri=urn:aaid:scds:US:61141008-001c-313b-ab9a-74d85bf46544">GUIDE Software</a></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-18"></td>
|
||
<td headers="table-index-product-page-link row-index-18"></td>
|
||
<td headers="table-index-company-contact- row-index-18"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-19" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-19">STIMVIEW/Vercise Neural Navigator Software</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-19">Y</td>
|
||
<td headers="table-index-application-/-original-indication row-index-19">Same as Vercise Genus System</td>
|
||
<td headers="table-index-regulatory-status row-index-19"> CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-19"><a href="https://acrobat.adobe.com/link/review?uri=urn:aaid:scds:US:fad3d6b5-85d5-3130-9c27-bd120fa3eedb">STIMVIEW/Vercise Neural Navigator SOFTWARE</a></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-19"></td>
|
||
<td headers="table-index-product-page-link row-index-19"></td>
|
||
<td headers="table-index-company-contact- row-index-19"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-20" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-20">8-Contact Deep Brain Stimulation Lead</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-20">Y</td>
|
||
<td headers="table-index-application-/-original-indication row-index-20">Same as Vercise Genus System</td>
|
||
<td headers="table-index-regulatory-status row-index-20">PMA; CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-20"><a href="https://acrobat.adobe.com/link/review?uri=urn:aaid:scds:US:7c3d712d-8264-3a3b-9acc-7f932ab9e7b4">8-Contact Deep Brain Stimulation Stimulation Lead (Standard Lead)</a></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-20"></td>
|
||
<td headers="table-index-product-page-link row-index-20"><a href="https://www.bostonscientific.com/en-US/products/deep-brain-stimulation-systems/vercise-genus-dbs-system/leads.html">Vercise Genus Deep Brain Stimulation System</a></td>
|
||
<td headers="table-index-company-contact- row-index-20"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-21" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-21">Directional 8-Contact Segmented Deep Brain Stimulation Lead</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-21">Y</td>
|
||
<td headers="table-index-application-/-original-indication row-index-21">Same as Vercise Genus System</td>
|
||
<td headers="table-index-regulatory-status row-index-21">PMA; CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-21"><a href="https://acrobat.adobe.com/link/review?uri=urn:aaid:scds:US:d1b69361-3c3d-39a2-a44b-ccba7067c15b">Directional Leads</a></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-21"></td>
|
||
<td headers="table-index-product-page-link row-index-21"><a href="https://www.bostonscientific.com/en-US/products/deep-brain-stimulation-systems/vercise-genus-dbs-system/leads.html">Vercise Genus Deep Brain Stimulation System</a></td>
|
||
<td headers="table-index-company-contact- row-index-21"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-22" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-22">CHRONOS Research Engine</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-22">N</td>
|
||
<td headers="table-index-application-/-original-indication row-index-22">N/A</td>
|
||
<td headers="table-index-regulatory-status row-index-22">IDE</td>
|
||
<td headers="table-index-accessories- row-index-22"><a href="https://acrobat.adobe.com/link/review?uri=urn:aaid:scds:US:d70079d4-7c9e-3162-8f0b-c189cfc045b4">Chronos Research Engine</a></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-22"></td>
|
||
<td headers="table-index-product-page-link row-index-22"></td>
|
||
<td headers="table-index-company-contact- row-index-22"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-23" headers="table-index-company">Boston Scientific</th>
|
||
<td headers="table-index-product row-index-23">WAVEWRITER ALPHA Spinal Cord Stimlator Systems</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-23">Y</td>
|
||
<td headers="table-index-application-/-original-indication row-index-23">The Boston Scientific Spinal Cord Stimulator (SCS) Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. Associated conditions and etiologies may be: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions): arachnoiditis, multiple back surgeries. Note: CRPS I was previously referred to as Reflex Sympathetic Dystrophy (RSD) and CRPS II was previously referred to as causalgia.</td>
|
||
<td headers="table-index-regulatory-status row-index-23">PMA; CE Mark</td>
|
||
<td headers="table-index-accessories- row-index-23"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/spinal_cord_stimulation_accessories_508c.pdf">Spinal Cord Stimulation Accessories (PDF- 314 KB)</a></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-23"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/precision_spinal_cord_stimulation_system_information_508c.pdf">Precision SPECTRA Spinal Cord Stimulator System</a></td>
|
||
<td headers="table-index-product-page-link row-index-23"><a href="https://www.bostonscientific.com/en-US/products/spinal-cord-stimulator-systems/wavewriter-alpha.html">Wavewriter Alpha</a></td>
|
||
<td headers="table-index-company-contact- row-index-23"><a href="mailto:Stephen.Carcieri@bsci.com">Stephen Carcieri</a></td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-24" headers="table-index-company">Cirtec Medical</th>
|
||
<td headers="table-index-product row-index-24">ACCEL+</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-24">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-24">SCS / Original Indication: ACCEL+ (Former Nuvectra Algovita) Spinal Cord Stimulation (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/ or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intract</td>
|
||
<td headers="table-index-regulatory-status row-index-24">Previously PMA and CE Mark approved device. Cirtec converted the PMA to a Device Master File (MAF) to support IRB, IDE, and PMA regulatory submissions.</td>
|
||
<td headers="table-index-accessories- row-index-24"><a href="https://cirtecmed.com/wordpress/wp-content/uploads/2021/04/simplifi_accelaccel_catalog_v3-4-6-21-v2.pdf">Accel+ Product Catalog (PDF- 1.7 MB)</a></td>
|
||
<td headers="table-index-device-information-&-company-support row-index-24"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/cirtec_accel_device_information_508c.pdf">Accel+ Device Information (PDF- 3.7 MB) </a><br> <a href="https://www.braininitiative.nih.gov/sites/default/files/pdfs/cirtec_exhibit_d_508c.pdf">Exhibit D: Company Support for Research Programs (PDF- 106 KB) </a> </td>
|
||
<td headers="table-index-product-page-link row-index-24"><a href="https://cirtecmed.com/wordpress/wp-content/uploads/2021/04/simplifi_accelaccel_catalog_v3-4-6-21-v2.pdf">Accel+ Product Catalog (PDF- 1.7 MB)</a></td>
|
||
<td headers="table-index-company-contact- row-index-24"><a href="mailto:adam.rand@cirtecmed.com">Adam Rand</a>, Business Development Manager</td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-25" headers="table-index-company">CorTec</th>
|
||
<td headers="table-index-product row-index-25">AirRay Electrodes</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-25">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-25">The electrode facilitates high-level data acquisition and stimulation in the central and peripheral nervous system It is made using patented high-precision laser manufacturing and offers a combination of advantageous product features like flexibility, softness, thinness as well as a high density of contacts </td>
|
||
<td headers="table-index-regulatory-status row-index-25">510(k) (<30 days)</td>
|
||
<td headers="table-index-accessories- row-index-25">Connection cable</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-25"><a href="https://braininitiative.nih.gov/sites/default/files/documents/2019-10_cortec_product_information_airrayelectrodes_508c.pdf">AirRay Electrodes Device Information (PDF- 782 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-25"><a href="https://cortec-neuro.com/?s=AirRay+Electrodes">Airway Electrodes</a></td>
|
||
<td headers="table-index-company-contact- row-index-25"><a href="mailto:sales@cortec-neuro.com">Christina Schwartz</a>, Head of Marketing & Sales</td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-26" headers="table-index-company">CorTec</th>
|
||
<td headers="table-index-product row-index-26">Hermetic Encapsulation</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-26">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-26">The hermetic encapsulation is an extremely robust ceramic package designed to protect sensitive electronics with a high amount of electrical feedthroughs for long-term applications It also offers electromagnetic transparency facilitating communication via radio frequency or infrared as well as inductive powering</td>
|
||
<td headers="table-index-regulatory-status row-index-26">None</td>
|
||
<td headers="table-index-accessories- row-index-26">NA</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-26"><a href="https://braininitiative.nih.gov/sites/default/files/documents/2019-10_cortec_product_information_hermeticencapsulation_508c.pdf">Hermetic Encapsulation Device Information (PDF- 310 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-26"><a href="https://cortec-neuro.com/?s=Hermetic+Encapsulation">Hermetic Encapsulation</a></td>
|
||
<td headers="table-index-company-contact- row-index-26"><a href="mailto:sales@cortec-neuro.com">Christina Schwartz</a>, Head of Marketing & Sales</td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-27" headers="table-index-company">CorTec</th>
|
||
<td headers="table-index-product row-index-27">CorTec Brain Interchange</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-27">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-27">CorTec Brain Interchange is a highly efficient closed-loop technology designed for chronic recording and stimulating the brain's activity in humans As a closed-loop system, CorTec Brain Interchange can control neurostimulation in real-time based on brain activity recorded simultaneously and adjust its activities</td>
|
||
<td headers="table-index-regulatory-status row-index-27">None</td>
|
||
<td headers="table-index-accessories- row-index-27">C++ Interface External telemetry unit</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-27"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/2019-10_cortec_product_information_braininterchange_508c.pdf">CorTec Brain Interchange Device Information (PDF- 599 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-27"><a href="https://cortec-neuro.com/?s=Brain+Interchange">Brain Interchange</a></td>
|
||
<td headers="table-index-company-contact- row-index-27"><a href="mailto:sales@cortec-neuro.com">Christina Schwartz</a>, Head of Marketing & Sales</td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-28" headers="table-index-company">NeuroNexus</th>
|
||
<td headers="table-index-product row-index-28">High-definition Electrodes</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-28">No</td>
|
||
<td headers="table-index-application-/-original-indication row-index-28">Neural recording / stimulation (customizable)</td>
|
||
<td headers="table-index-regulatory-status row-index-28">None</td>
|
||
<td headers="table-index-accessories- row-index-28">Contact Company Representative </td>
|
||
<td headers="table-index-device-information-&-company-support row-index-28"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/ppp_neuronexus_high_def_electrodes_508c.pdf">High-definition Electrodes Device Information (PDF- 370 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-28">Not available</td>
|
||
<td headers="table-index-company-contact- row-index-28"><a href="mailto:dkipke@neuronexus.com">Daryl Kipke</a>, President, NeuroNexus</td>
|
||
</tr>
|
||
<tr>
|
||
<th scope="row" id="row-index-29" headers="table-index-company">NeuroPace, Inc</th>
|
||
<td headers="table-index-product row-index-29">RNS System for Responsive Neurostimulation</td>
|
||
<td headers="table-index-prior-use-in-humans row-index-29">Yes</td>
|
||
<td headers="table-index-application-/-original-indication row-index-29">The RNS System is an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and / or secondarily generalized seizures) The RNS System has demonstrated safety and effectiveness in patients who average 3 or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures), and has not been evaluated in patients with less frequent seizures. </td>
|
||
<td headers="table-index-regulatory-status row-index-29">PMA</td>
|
||
<td headers="table-index-accessories- row-index-29">Neurostimualtor, Leads, Programmer, Remote Monitor, Research Accessories</td>
|
||
<td headers="table-index-device-information-&-company-support row-index-29"><a href="https://www.braininitiative.nih.gov/sites/default/files/documents/ppp_rns_device_info_508c.pdf">RNS System Information (PDF- 70 KB)</a></td>
|
||
<td headers="table-index-product-page-link row-index-29"><a href="http://www.neuropace.com/the-rns-system/">RNS System</a></td>
|
||
<td headers="table-index-company-contact- row-index-29"><a href="mailto:ttcheng@neuropace.com">Tom Tcheng</a>, Sr Director of Preclinical R&D</td>
|
||
</tr>
|
||
</tbody>
|
||
</table>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
</article>
|
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|
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|
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|
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|
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