Medtronic, Inc. (NYSE: MDT) today announced that it has received from Health Canada a license for Medtronic Deep Brain Stimulation (DBS) Therapy for refractory epilepsy patients. Medtronic DBS therapy for refractory epilepsy delivers controlled electrical pulses to a location inside the brain which is involved in seizures.
The Health Canada license was based on data collected in Medtronic's clinical trial called SANTE® (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy). The SANTE trial was a prospective, randomized, double-blind pivotal study to evaluate the use of DBS therapy for patients with medically refractory epilepsy with partial-onset seizures. The trial collected data from 110 patients who were implanted with a Medtronic DBS system at 17 centers in the United States.
Medtronic DBS Therapy for refractory epilepsy is also approved in Europe. The therapy is not currently approved by the U.S. Food and Drug Administration for use in the United States for the treatment of refractory epilepsy.
To date, more than 85,000 patients worldwide have received Medtronic DBS therapy. The therapy is currently licensed in Canada and approved in other regions including the European Union and the United States, for the treatment of the disabling symptoms of essential tremor, advanced Parkinson's disease and dystonia, for which approval in the United States is under a Humanitarian Device Exemption (HDE). The therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder not adequately controlled by medications in the European Union and in the United States under an HDE.
"Medtronic is a pioneer in the field of neuromodulation," said Lothar Krinke, Ph.D., vice president and general manager for the Deep Brain Stimulation business in Medtronic's Neuromodulation division. "We are proud of the expansion of indications to include epilepsy, which will allow more patients to benefit from our DBS therapy. This Medtronic First innovation provides a viable option for patients who are not responsive to other therapies. This follows closely the Canadian launch of the RestoreSensor™ neurostimulator for chronic pain, another Medtronic first. "