FDA approves Deep Brain Stimulation for Epilepsy.-Medtronic

Medtronic plc announced both the U.S. launch of Deep Brain Stimulation (DBS) for medically-refractory epilepsy and the first commercially implanted patient at Emory University in Atlanta, Ga. According to the Epilepsy Foundation, as many as 3.4 million Americans have epilepsy, with one-third estimated to be drug resistant.

DBS therapy for epilepsy delivers controlled electrical pulses to a target in the brain called the anterior nucleus of the thalamus (ANT), which is part of a network involved in seizures. Recently, the FDA granted pre-market approval for Medtronic DBS Therapy for Epilepsy as adjunctive treatment for reducing the frequency of partial-onset seizures in individuals 18 years of age or older who are refractory, or drug-resistant, to three or more antiepileptic medications. The approval was based on results from the SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) trial, wherein patients had a median seizure frequency reduction of 75 percent at seven years post-implant.