Medtronic Inc.’s (NYSE: MDT) Deep Brain Stimulation Therapy has received CE Mark approval in Europe to help adults who have hard-to-treat epilepsy.
The therapy that delivers controlled electrical pulses to the brain to short-circuit seizures is investigational and being considered by the Food and Drug Administration for approval in the United States.
“Epilepsy that is refractory to current medical treatment is a severe, unsolved problem,” Dr. Eugen Trinka, head of neurology at the University Hospital Christian Doppler Klinik in Salzburg, Austria, said in a Medtronic release. “[Deep brain stimulation] 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.”
Medtronic has been studying deep brain stimulation (DBS) to treat epilepsy for several years through its SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) clinical trial. In March, a special panel of experts recruited by the FDA narrowly approved Medtronic’s device.
The close vote reflected the panel’s unease with the therapy. The FDA has said Medtronic failed to demonstrate that patients using the device experienced fewer seizures than patients in the control group who did not receive the therapy. The device also may have significant side-effects for people with epilepsy.
“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,” Tom Tefft, president of Medtronic’s Neuromodulation unit, said in his company’s release. “In the United States, we remain committed to working with FDA to determine the most appropriate path forward.”
Medtronic DBS therapy is approved in Europe and the United States to treat Parkinson’s disease, dystonia and obsessive-compulsive disorder.
