Public-Private Partnership Program: Devices & Support Specific Manufacturers

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. We suggest that you contact Dr. Nick Langhals, and the company representative listed prior to application submission.

 

 

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
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 IRB Connection cable AirRay Electrodes Device Information (PDF- 330 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- 220 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- 485 KB) Brain Interchange Christina Schwartz, Head of Marketing & Sales
Medtronic Summit RC+S Yes Parkinson's, Essential Tremor, Dystonia, Epilepsy IDE, IRB Full System/algorithm toolkit RC+S Device Information (PDF- 282 KB) Not available Robert Raike, Chief Scientist, DBS Therapies
Medtronic Next Generation Primary Cell + Sensing DBS Device (not yet available) No Chronic brain sensing and adaptive stimulation None Full System/algorithm toolkit Next Generation Primary Cell + Sensing DBS Device Information (PDF- 132 KB) Not available Robert Raike, Chief Scientist, DBS Therapies
Medtronic Nexus Systems (-D [distributed] and -E [embedded]) Yes Parkinson's, Essential Tremor, Dystonia, Epilepsy IDE, IRB, CE Mark Full System/algorithm toolkit Nexus Systems Device Information (PDF- 156 KB) Not available Robert Raike, Chief Scientist, DBS Therapies
Medtronic RestoreSensor Yes Chronic Pain PMA Full System Restore Sensor Device Information (PDF- 172 KB) Restore Sensor Nathan Torgerson
Medtronic LINQ Yes Unexplained Fainting PMA Full System LINQ Device Information (PDF- 207 KB) LINQ Robert Raike, Chief Scientist, DBS Therapies
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
Second Sight Argus II Retinal Prosthesis System Yes Retinitis Pigmentosa HDE, CE Mark Contact Company Representative Argus II Retinal Prosthesis System Information (PDF- 275 KB) Argus II Retinal Prosthesis System Jessy Dorn, Sr Director of Scientific Research
Second Sight Orion I Cortical Visual Prosthesis System Yes Blindness due to non-cortical etiology IDE Contact Company Representative Orion I Cortical Visual Prosthesis System Information (PDF- 130 KB) Not available Jessy Dorn, Sr Director of Scientific Research