The NeuroPace RNS System is the first FDA-approved closed-loop brain stimulation device, designed specifically for drug-resistant focal epilepsy. A neurostimulator the size of a matchbook is implanted in a cranial recess; up to two leads with strip or depth electrodes are placed at seizure foci. The device continuously monitors cortical EEG in real time, detects abnormal electrical patterns indicative of impending seizures, and automatically delivers brief counter-stimulation pulses — entirely without patient action. Long-term follow-up data from the RESPONSE trial shows a median 75% reduction in seizures at 9 years post-implant, with some patients achieving seizure freedom.
The device has received Pre-Market Approval (PMA) from the FDA, the most stringent device marketing pathway. PMA approval means FDA has found there is reasonable assurance the device is safe and effective.
FDA Device Regulatory Guidance ↗