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Pivotal Trial Data Demonstrate NeuroPace RNS(R) System Reduced Seizures in People With Epilepsy
Date:12/7/2009

rienced a mean percentage reduction of 29 percent in their disabling seizures compared to 14 percent reduction for those in the sham stimulation group. In the long term, open label period of the trial, at least 12 weeks of data were available for 171 study participants; 47 percent of these subjects experienced a 50 percent or greater reduction in their seizure frequency based on their most recent 12 weeks of data, as compared to their baseline.

The trial also demonstrated a serious adverse event rate less than comparative surgical procedures. There were no serious unanticipated device related adverse events reported in the trial. There was no difference between the treatment and sham stimulation groups when comparing the rate of adverse events, including depression, memory impairment and anxiety.

To download a copy of the press kit and images of the RNS System, please visit: http://bit.ly/RNSSystem

About the RNS System

The RNS System is designed with novel technology to detect abnormal electrical activity in the brain and then deliver small amounts of electrical stimulation to suppress the abnormal activity before any seizure symptoms occur. This type of treatment is called responsive stimulation and differs from deep brain stimulation, which delivers stimulation continuously or on a pre-set schedule. With the RNS System, physicians have the ability to non-invasively program the detection and stimulation parameters of an implanted RNS Neurostimulator specifically for individual patients.

About the RNS System Pivotal Clinical Trial

Trial Patient Population

The RNS System Pivotal Clinical Investigation is a randomized, double-blind, sham stimulation controlled investigation that included 191 people implanted with the RNS System across 31 sites. All subjects in the study were required to be 18 or older and have partia
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SOURCE NeuroPace, Inc.
Copyright©2009 PR Newswire.
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