NeuroPace Seeks FDA Approval for Its RNS System

Mountain View, CA based NeuroPace, Inc. has submitted a Premarket Approval application to the FDA, seeking clearance for its RNS™ System. The technology, which we have previously covered here at Medgadget, is designed to decrease or eliminate epilepsy episodes through the use of an implant which monitors the patient’s brain, and delivers electric signals to prevent seizures by disrupting any abnormal activity which it detects.
From the press release:

The PMA application is for an indication to treat people with medically refractory partial onset epilepsy originating from one or two locations in the brain. Partial onset epilepsy is a common form of the disorder that is difficult to treat with medication. Results from the company’s pivotal trial were included in the PMA application. The data, some of which were presented at the American Epilepsy Society’s (AES) 63rd Annual Meeting in December 2009, were collected from 191 people with medically refractory partial onset epilepsy enrolled at 31 sites located in the United States. The results demonstrate the RNS System significantly reduced the frequency of disabling seizures.

Press release: NeuroPace Submits PMA Application for FDA Approval of Novel Investigational Device for Epilepsy…
Product page: RNS System…
Flashbacks: NeuroPace: Maybe First Since Jesus to Prevent and Treat Epilepsy; Neuropace Implantable Epilepsy Device Showing Positive Signs in Initial Clinical Study; Promising Results Released in Controlling Epilepsy via Deep Brain Stimulation