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

l onset epilepsy, with seizures that start from one or two areas of the brain, that has not been effectively treated with two or more antiepileptic medications alone or in combination.

Trial Design

Patients in the study were implanted with the RNS System once eligibility criteria were met. The blinded evaluation period of the trial began eight weeks after the RNS System was implanted and lasted an additional 12 weeks. Half the participants were randomly assigned to have responsive stimulation activated and half had responsive stimulation remain inactive. Participants and one doctor at each site in the trial did not know whether the stimulation was active or not. A separate doctor at each site programmed the device for people in the treatment group in order to keep the data blinded. Five months after the RNS System was implanted, which is when the double-blinded portion of the trial was completed, stimulation was activated for all participants in the trial. This portion of the trial, which produced long term data, is called the open label period. Each participant will be evaluated in the pivotal trial for two years after being implanted with the RNS System. After completing the pivotal trial, participants have the option to enroll in a subsequent trial designed to gather an additional five years of safety and efficacy data.

About NeuroPace

NeuroPace was founded to design, develop, manufacture and market implantable devices for the treatment of neurological disorders by responsive brain stimulation. The company's initial focus is the treatment of epilepsy, a debilitating neurological disorder affecting approximately one percent of the population worldwide. An estimated 30-40 percent of the 50 million people worldwide, including more than 3 million Americans, experience uncontrolled seizures. In addition to treating epilepsy, responsive neurostimulation holds the promise of treating several other disabling medi
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SOURCE NeuroPace, Inc.
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