Medtronic announced that a publication highlighting results from the pivotal study for Medtronic DBS Therapy for epilepsy, known as SANTE, was published online in the medical journal, Epilepsia. 

The SANTE study, sponsored by Medtronic, is the largest and most rigorous clinical study of DBS therapy for epilepsy in adults with medically refractory epilepsy with partial-onset seizures. Today’s publication includes results from the blinded phase of the study and through two years of therapy. Medtronic DBS therapy is under review by the U.S. Food and Drug Administration ( FDA ). 

Medtronic DBS Therapy for Epilepsy is investigational and uses a pacemaker-like device to deliver individualized, targeted and precise electrical stimulation to a specific target in the brain called the anterior nucleus of the thalamus, which is part of a circuit involved in seizures. Medtronic has submitted a supplemental Pre-Market Approval (PMA) application for DBS Therapy for Epilepsy that remains under review by the FDA. On March 12, 2010, the FDA Neurological Devices Panel of the Medical Devices Advisory Committee voted to recommend U.S. FDA approval with conditions for DBS therapy for epilepsy as adjunctive treatment for partial-onset seizures in adults with medically refractory epilepsy.

“DBS therapy for epilepsy is another important example of Medtronic’s commitment to develop innovative solutions for patients with chronic, debilitating diseases,” said Tom Tefft, senior vice president and president of Medtronic ’s Neuromodulation business. “We will work closely with the FDA to address the conditions of approval proposed by the FDA panel so that we can make this therapy available to patients with epilepsy who have limited treatment options.” 

Source : Medtronic