The U.S. Food and Drug Administration (FDA) Neurological Devices Panel voted unanimously (11 to 0 with two abstentions) that the clinical benefits of the NeuroPace RNS System outweigh the risks of its use. NeuroPace is seeking approval for the RNS System for treating adults with partial onset seizures that have not been controlled with two or more antiepileptic medications. The final decision regarding approval of the device is made by the FDA.
"The Epilepsy Foundation supports new innovations in therapy for epilepsy including the responsive neurostimulation device for epilepsy," said Dr. Joseph Sirven, Chair of the Epilepsy Foundation's Professional Advisory Board and Editor-in-Chief of epilepsy.com. "The clinical research conducted on this device was meticulous and detailed. For patients, where surgery is not an option, this device provided life saving improvement in quality of life. Moreover, the fact that the device also records continuous EEG signal that can be transmitted to a physician miles away is the ultimate telemedicine device for individualized medicine. This tool is an important addition to the therapeutic arsenal against chronic epilepsy."
"We have worked for over 15 years to develop and clinically evaluate the RNS System. We are very excited that patients and physicians who need new treatment options so desperately are now likely to have the RNS System commercially available in the near future," said Frank Fischer, NeuroPace CEO.
The RNS System has been evaluated in three clinical trials, including the prospective, randomized, double blinded, sham-stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9% reduction in seizure frequency in the treatment group compared to a 17.3% reduction in the sham-stimulation control group during a three month blinded evaluation period. This difference was statistically significant (p=0.012). Long-term results demonstrated sustained improvements in seizure frequency with median seizure frequency reductions of 44% and 53% at one and two years post-implant, respectively.
"There is strong clinical evidence that this new therapy offers substantial benefits to a significant population of people with medically refractory partial onset seizures," said Martha Morrell, MD, NeuroPace Chief Medical Officer and Clinical Professor of Neurology at Stanford University. "We look forward to working closely with the FDA to finalize both the labeling and the post-approval study commitments so that this technology can become available to patients as quickly as possible."
Warren Lammert, Epilepsy Foundation board member and co-founder of the Epilepsy Therapy Project spoke at the panel: "Epilepsy needs new, effective therapies. The RNS is one good option. Moreover, it is an approach that offers a new window on epilepsy, a path to progress in our understanding and treatment. All new therapies involve unknowns and risks, but these have to be weighed against the risks and too often devastating, even fatal reality of uncontrolled seizures. People with uncontrolled epilepsy, together with their families and doctors, deserve the opportunity to weigh the costs and risks of their epilepsy against the risks and promise of this new therapy which has been shown to be effective in appropriate clinical trials."
FDA accepted the company's Premarket Approval (PMA) application in November 2010 based on data from the pivotal study. A total of 256 patients have been implanted with the RNS System, and more than 1,200 patient years of experience with responsive stimulation have been accumulated to date.