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Home » FDA advisory votes against BrainsGate’s neurostim device for treating stroke

FDA advisory votes against BrainsGate’s neurostim device for treating stroke

December 13, 2021 By Sean Whooley

BrainsGate LogoAt the end of last week, an FDA advisory panel voted down BrainsGate’s neurostimulation device for treating stroke.

BrainsGate designed its technology as a five-minute procedure. A neurostimulator implant is injected into an existing canal to stimulate a nerve center and augment collateral blood flow, improving stroke patients’ outcomes within a 24-hour window.

The platform has CE mark approval, and BrainsGate initially applied for FDA premarket approval in February 2020.

Meeting on Friday, the panel voted 7-3 (with three abstentions) against the device, determining that the benefits of BrainsGate’s treatment did not outweigh the risk for patients. The panel found a reasonable assurance of effectiveness was not provided, although assurance of safety was evident, according to an FDA executive summary.

A major hangup for the panel was that the device changed during BrainsGate’s clinical trial of more than 1,000 subjects, as did the objectives, potentially compromising outcomes. The FDA can now review the panel’s ruling before handing down its own decision.

Filed Under: Blood Management, Featured, Food & Drug Administration (FDA), Implants, Neurological, Neuromodulation/Neurostimulation, News Well, Regulatory/Compliance Tagged With: BrainsGate, FDA, FDA advisory panels

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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