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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.
File
| Company | Product | Prior use in Humans | Application / Original Indication | Regulatory Status | Accessories | Device Information & Company Support | Product Page Link | Company Contact |
|---|---|---|---|---|---|---|---|---|
| Abbott | Infinity DBS | Yes | 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 | PMA, CE Marked | Clinician Programmer, Patient Controller, Burr Hole Cover, Infinity and Traditional Leads, Lead Extension | Infinity DBS Device Information (PDF- 305 KB) | Infinity DBS | Binith Cheeran, Director of Medical Affairs |
| Abbott | Proclaim SCS | Yes | 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 | PMA, CE Marked | Clinician Programmer, Patient Controller, Percutaneous and Paddle Leads | Proclaim Elite SCS Device Information (PDF- 365 KB) | Proclaim Elite SCS | Binith Cheeran, Director of Medical Affairs |
| Abbott | Prodigy SCS | Yes | 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 | PMA, CE Marked | Clinician Programmer, Patient Controller, Percutaneous and Paddle Leads | Prodigy MRI SCS Device Information (PDF- 311 KB) | Prodigy MRI | Binith Cheeran, Director of Medical Affairs |
| Abbott | Proclaim DRG | Yes | 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 | PMA, CE Marked | Clinician Programmer, Patient Controller, Percutaneous Leads | Proclaim DRG Device Information (PDF- 295 KB) | Proclaim DRG | Binith Cheeran, Director of Medical Affairs |
| Blackrock Microsystems | NeuroPort Electrode Array | Yes | Recording and monitoring of intracortical activity | 510(k) (<30 days), IDE/IRB (>30 days) | Engineering Expertise, Regulatory Assistance, Data Repository | NeuroPort Electrode Array Device Information (PDF- 1.2 MB) | Neuroport Electrode Array | Florian Solzbacher |
| Blackrock Microsystems | Utah Slanted Electrode Array | Yes | Intrafascicular microelectrode array for peripheral nerve applications | IDE | Engineering Expertise, Regulatory Assistance, Data Repository | Utah Slanted Electrode Array Device Information (PDF- 455 KB) | Utah Slanted Electrode Array | Florian Solzbacher |
| Blackrock Microsystems | NeuroPort Biopotential Signal Processing System | Yes | 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 | 510(k) | Engineering Expertise, Regulatory Assistance, Data Repository | NeuroPort Biopotential Signal Processing System Device Information (PDF- 163 KB) | NeuroPort Biopotential Signal Processing System | Florian Solzbacher |
| Blackrock Microsystems | Cervello Elite | Yes | 128 or 256 channel combined video EEG and microelectrode data acquisition system | 510(k) | Engineering Expertise, Regulatory Assistance, Data Repository | Cervello Elite Device Information (PDF- 157 KB) | Not available | Florian Solzbacher |
| Blackrock Microsystems | CerePlex I | Yes | 128 channel fully implantable integrated electrode and amplifier system | IDE/IRB | Engineering Expertise, Regulatory Assistance, Data Repository | CerePlex I Device Information (PDF- 232 KB) | Not available | Florian Solzbacher |
| Blackrock Microsystems | CereStim | Yes | 96 channel stimulator for micro and macro electrodes | IDE/IRB | Engineering Expertise, Regulatory Assistance, Data Repository | CereStim Device Information (PDF- 173 KB) | CereStim Device | Florian Solzbacher |
| Blackrock Microsystems | Electrode Inserter System | Yes | Pneumatic electrode array insertion system | 510(k) | Engineering Expertise, Regulatory Assistance, Data Repository | Electrode Inserter System Device Information (PDF- 316 KB) | Electrode Inserter System | Florian Solzbacher |
| Blackrock Microsystems | Splitter Box | Yes | Headstage allowing Blackrock NeuroPort Biopotential Signal Processing System to share electrode signals with 3rd party acquisition systems | 510(k) | Contact Company Representative | Splitter Box Device Information (PDF- 271 KB) | Splitter Box | Florian Solzbacher |
| Boston Scientific | Vercise Deep Brain Stimulation System | Yes | DBS for Parkinson's Disease | PMA; CE Mark | Deep Brain Stimulation Accessories (PDF- 444 KB) | Vercise Deep Brain Stimulation System Information (PDF- 340 KB) | Vercise Deep Brain Stimulation System | Stephen Carcieri |
| Boston Scientific | Precision Spectra; Precision Wavewriter; Precision Novio; Precision Montage Spinal Cord Stimulator System | Yes | 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 | PMA; CE Mark | Spinal Cord Stimulation Accessories (PDF- 314 KB) | Precision Spinal Cord Stimulation System Information (PDF- 455 KB) | Precision Spinal Cord Stimulation System | Stephen Carcieri |
| Boston Scientific | VERCISE Genus Deep Brain Stimulation System | Y | 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. | PMA; CE Mark | Vercise Genus System | Vercise Genus Deep Brain Stimulation (DBS) System | Stephen Carcieri | |
| Boston Scientific | VERCISE Gevia Deep Brain Stimulation System | Y | Same as Vercise Genus System | PMA; CE Mark | Vercise Gevia and Vercise PC System | Vercise Gevia DBS System | Stephen Carcieri | |
| Boston Scientific | VERCISE PC Deep Brain Stimulation system | Y | Same as Vercise Genus System | PMA; CE Mark | Vercise Gevia and Vercise PC System | Vercise PC DBS System | Stephen Carcieri | |
| Boston Scientific | GUIDE XT DBS Software | Y | 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. | CE Mark | GUIDE Software | Stephen Carcieri | ||
| Boston Scientific | STIMVIEW/Vercise Neural Navigator Software | Y | Same as Vercise Genus System | CE Mark | STIMVIEW/Vercise Neural Navigator SOFTWARE | Stephen Carcieri | ||
| Boston Scientific | 8-Contact Deep Brain Stimulation Lead | Y | Same as Vercise Genus System | PMA; CE Mark | 8-Contact Deep Brain Stimulation Stimulation Lead (Standard Lead) | Vercise Genus Deep Brain Stimulation System | Stephen Carcieri | |
| Boston Scientific | Directional 8-Contact Segmented Deep Brain Stimulation Lead | Y | Same as Vercise Genus System | PMA; CE Mark | Directional Leads | Vercise Genus Deep Brain Stimulation System | Stephen Carcieri | |
| Boston Scientific | CHRONOS Research Engine | N | N/A | IDE | Chronos Research Engine | Stephen Carcieri | ||
| Boston Scientific | WAVEWRITER ALPHA Spinal Cord Stimlator Systems | Y | 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. | PMA; CE Mark | Spinal Cord Stimulation Accessories (PDF- 314 KB) | Precision SPECTRA Spinal Cord Stimulator System | Wavewriter Alpha | Stephen Carcieri |
| Cirtec Medical | ACCEL+ | Yes | 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 | 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. | Accel+ Product Catalog (PDF- 1.7 MB) | Accel+ Device Information (PDF- 3.7 MB) Exhibit D: Company Support for Research Programs (PDF- 106 KB) |
Accel+ Product Catalog (PDF- 1.7 MB) | Adam Rand, Business Development Manager |
| CorTec | AirRay Electrodes | Yes | 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 | 510(k) (<30 days) | Connection cable | AirRay Electrodes Device Information (PDF- 782 KB) | Airway Electrodes | Christina Schwartz, Head of Marketing & Sales |
| CorTec | Hermetic Encapsulation | Yes | 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 | None | NA | Hermetic Encapsulation Device Information (PDF- 310 KB) | Hermetic Encapsulation | Christina Schwartz, Head of Marketing & Sales |
| CorTec | CorTec Brain Interchange | Yes | 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 | None | C++ Interface External telemetry unit | CorTec Brain Interchange Device Information (PDF- 599 KB) | Brain Interchange | Christina Schwartz, Head of Marketing & Sales |
| NeuroNexus | High-definition Electrodes | No | Neural recording / stimulation (customizable) | None | Contact Company Representative | High-definition Electrodes Device Information (PDF- 370 KB) | Not available | Daryl Kipke, President, NeuroNexus |
| NeuroPace, Inc | RNS System for Responsive Neurostimulation | Yes | 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. | PMA | Neurostimualtor, Leads, Programmer, Remote Monitor, Research Accessories | RNS System Information (PDF- 70 KB) | RNS System | Tom Tcheng, Sr Director of Preclinical R&D |