NeuroPace Treats 1,000th Patient with RNS System for Medically Refractory Epilepsy

NeuroPace Inc. said the 1000th patient has been treated with its RNS System, approved by the U.S. Food and Drug Administration in November 2013. Similar to a pacemaker that monitors and responds to heart rhythms, the RNS System is the first and only medical device that can monitor and respond to the brain’s electrical activity.
 
 “The RNS System is rapidly gaining recognition among physicians and patients as a proven treatment option for patients whose seizures are not controlled by medication,” said Frank Fischer, CEO of NeuroPace. “It is truly rewarding to see the very positive impact that this innovative technology has had on the lives of so many patients and their families.”
 
One of those patients is Tammey, a registered nurse, and mother of one. “It has changed my life in so many ways,” she said. “I have the freedom and security that I thought I would never feel again. I am now working on restarting my bucket list!”

A recent study presented at the 2016 American Epilepsy Society Annual Meeting showed that the median reduction in seizure frequency was 72 percent at seven years (N=185). During the seventh year post-implant, 25 percent of patients had a seizure reduction of greater than or equal to 93 percent.¹ Additionally, nearly 30 percent of patients experienced at least one six month period of seizure freedom. The study enrolled 256 medically refractory epilepsy patients at 32 Comprehensive Epilepsy Centers in the United States.

One in 26 Americans will develop epilepsy in their lifetime, with approximately 150,000 new cases of epilepsy diagnosed annually. An estimated 3 million Americans currently live with epilepsy. More people live with epilepsy than autism spectrum disorder, Parkinson’s disease, multiple sclerosis and cerebral pals—combined.²

The RNS System is the first closed-loop brain-responsive neurostimulation system designed to prevent epileptic seizures at their source. The RNS System treats seizures by continuously monitoring brainwaves, detecting unusual activity, and automatically responding with imperceptible electrical pulses, often before seizure symptoms occur.
 
The RNS System has been evaluated in three clinical trials, including a prospective, randomized, double-blinded, sham stimulation controlled pivotal study and the long-term treatment study. Results of the clinical trials demonstrate the substantial clinical improvements experienced by patients over the short and long-term are meaningful and durable over many years of therapy. At this time, some patients have been treated with the RNS System for more than 11 years, and more than 1,700 patient years of experience with brain-responsive neurostimulation have been accumulated to date.
 
The RNS System is an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than two epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures).

NeuroPace designs, develops, manufactures and markets implantable devices for the treatment of neurological disorders with responsive stimulation. The Mountain View, Calif.-based company’s initial focus is the treatment of epilepsy, a debilitating neurological disorder affecting approximately 1 percent of the population worldwide.
 
References:
1 American Epilepsy Society Meeting, 2016
2 Epilepsy Foundation. “Facts about Seizures and Epilepsy.” http://www.epilepsy.com/learn/epilepsy-101/facts-about-seizures-and-epilepsy