MOUNTAIN VIEW, California – February 20, 2017 – NeuroPace, Inc. announced today that the 1000th patient has been treated with its award-winning RNS® System, approved by the FDA 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” says 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 says. “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 patients experienced a 72% median seizure reduction with the RNS® System over a 7 year period,1 including 25% who experienced seizure reductions of 93% or greater. Additionally, nearly 30% 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.
1 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 palsy – combined.3
About the RNS® System
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 LTT study. Results of the clinical trials demonstrate that 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.
Indication for Use
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). The RNS® System has demonstrated safety and effectiveness in patients who average three or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures), and has not been evaluated in patients with less frequent seizures.
NeuroPace is an innovative medical device company dedicated to improving quality of life for individuals with medically refractory epilepsy.
For more information, visit www.neuropace.com/patients/rns-system/
1 American Epilepsy Society Meeting, 2016
2 Institute of Medicine
3 Epilepsy Foundation. “Facts about Seizures and Epilepsy.” http://www.epilepsy.com/learn/epilepsy-101/facts-about-seizures-and-epilepsy