NeuroPace's RNS System
This article was originally published in The Gray Sheet
Executive Summary
Firm submits PMA application to treat medically refractory partial onset epilepsy with its RNS System implant. The device is unique in that it is designed to detect abnormal electrical activity in the brain and then deliver small amounts of electrical stimulation to suppress a seizure before it occurs - referred to as responsive neurostimulation. This "differs from the continuous or intermittent stimulation provided by commercially available neurostimulation systems," the company explains. The privately held firm's 191-patient randomized pivotal U.S. trial showed that the device reduced seizure frequency by 37.9% after three months compared to 17.3% for sham treatment - a statistically significant difference, according to NeuroPace. While Cyberonics' VNS Therapy vagus nerve stimulation implant is currently the only FDA-approved implant for drug refractory epilepsy, Medtronic expects to gain U.S. approval for its DBS deep brain stimulation implant for epilepsy later this year following an FDA panel endorsement in March (1"The Gray Sheet" March 15, 2010)