The European Commission (EC) has granted the Conformité Européenne (CE) Mark for deep brain stimulation (DBS) therapy (Medtronic, Inc) as adjunctive treatment for partial-onset seizures in adults with medically refractory epilepsy. DBS therapy using a Medtronic device is expected to be available in epilepsy centers across the European Union by the end of 2010.

“Epilepsy that is refractory to current medical treatment is a severe, unsolved problem,” said Professor Eugen Trinka, MD, MSc, in a company news release. “DBS therapy for epilepsy will be an important new treatment option for many patients in Europe with severe epilepsy who are not able to control their seizures with currently available drugs.” Dr. Trinka is head of neurology at the University Hospital’s Christian Doppler Klinik in Salzburg, Austria.

CE Mark approval was based on 2-year data from the prospective, randomized, multicenter, double-blind pivotal Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy study of 110 patients. As reported by Medscape Medical News, results showed that use of the DBS device decreased the frequency of seizures by a median of 56%; 14 patients (12.7%) remained seizure-free for at least 6 months.

Long-term data from the study were presented at the American Epilepsy Society meetings in December 2008 and December 2009 and were published in Epilepsia in March 2010.

Use of the DBS device for refractory epilepsy is investigational in the United States and is under review by the US Food and Drug Administration (FDA). The agency recently requested additional information to support the approval, which will require further clinical study.

“This CE Mark is the first approval by a regulatory agency for the use of DBS therapy in severe epilepsy and provides a new treatment option for patients in Europe who are in need of other options,” said Tom Tefft, senior vice president of Medtronic, Inc, and president of the neuromodulation business unit, in the news release. “In the United States, we remain committed to working with FDA to determine the most appropriate path forward.”

DBS indications previously cleared by the FDA and EC include the treatment of essential tremor and advanced Parkinson’s disease. The EC has also approved DBS for dystonia and obsessive-compulsive disorder — applications that are only approved for humanitarian use in the United States.