At 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 in which 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 as 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 the fact that the device changed during the course of 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.