Nov 16, 2013
NeuroPace Gets FDA Pre-Market Approval for RNS Stimulator
NeuroPace has received FDA pre-market approval for the NeuroPace RNS System, used to treat medically refractory partial epilepsy. The battery powered device is implanted in the cranium and monitors electrical activity in the brain. If abnormal activity is detected, electrical impulses are sent to the seizure focus in the brain via leads, helping to prevent the onset of a seizure. The RNS System also comes with a programmer for physicians to non-invasively set the detection and stimulation parameters for the implanted device, and has the ability to view the patients electrocorticogram (ECoG) in real time and upload previously recorded ECoGs stored on the RNS implant.
Results from clinical studies show significant benefits for patients, with a 37.9% reduction in seizure frequency for subjects with active implants. Follow up with patients two years post-implant showed that over half experienced a reduction in seizures of 50% or more.