SEATTLE, April 21, 2008 -- Epilepsy is a chronic neurological condition affecting more than 2.5 million Americans of all ages. Despite treatment with antiepileptic medications, about 40 percent to 50 percent of people with epilepsy continue to experience seizures or have intolerable medication side effects.
Epilepsy surgery may be an option for some people with refractory (hard-to-treat) epilepsy. However, many people cannot have surgery because it would be too risky and/or is unlikely to be helpful. As a result, new therapies for epilepsy are needed. Brain devices to treat epilepsy are currently being studied and may offer hope to people with epilepsy who are not adequately treated by antiepileptic medication and are not candidates for epilepsy surgery.
NeuroPace, Inc. is sponsoring an investigational device study of the RNS System, the company's responsive brain stimulation system for treating refractory epilepsy. The RNS System Pivotal Clinical Investigation is a randomized, double-blind, sham stimulation controlled investigation being conducted at about 28 sites throughout the United States. The purpose of the RNS System Pivotal Clinical Investigation is to assess the safety and to demonstrate that the RNS System is effective as an add-on (adjunctive) therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures (those that start from one or two areas of the brain) that are refractory (resistant or hard-to-treat) to two or more antiepileptic medications. Participants in the trial will continue to receive their epilepsy medications.