The U.S. Food and Drug Administration (FDA) Neurological Devices Panel today voted seven to five to recommend approval with conditions of Deep Brain Stimulation (DBS) Therapy for Epilepsy from Medtronic, Inc. (NYSE: MDT) as adjunctive treatment for partial-onset seizures in adults with medically refractory epilepsy. If the FDA follows the recommendation of the panel, the therapy will be approved for the treatment of epilepsy in patients who have continued seizures with inadequate response to currently available epilepsy treatments.
“Epilepsy and its unpredictable seizures can have a major impact on work, school, family life and social functioning, especially for the estimated one-third of individuals who continue to have seizures despite trying a range of treatment options”
“Epilepsy and its unpredictable seizures can have a major impact on work, school, family life and social functioning, especially for the estimated one-third of individuals who continue to have seizures despite trying a range of treatment options,” said Robert Fisher, M.D., Ph.D., professor of neurology and director of the Stanford Epilepsy Center in Palo Alto, Calif. “Today’s FDA expert panel recommendation affirms that potential benefits outweigh risk for appropriate patients with refractory epilepsy. This new therapy would be a welcome addition to our treatment possibilities.”
The panel recommended approval with conditions, including a post-approval study for long term follow up and labeling requirements. The FDA panel reviewed data from a U.S. clinical trial called SANTE® (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) involving 110 patients from 17 U.S. trial centers who had severe epilepsy for an average of 22 years prior to study enrollment.
“We are pleased with the FDA panel’s recommendation today and will work closely with the FDA to address the conditions of approval so that we are able to bring expanded DBS Therapy to market in the United States,” said Tom Tefft, senior vice president of Medtronic, Inc., and president of the Neuromodulation business unit. “We’re proud to partner with leading research centers and physicians to continue the pursuit of appropriate applications for DBS therapy for the benefit of patients.”
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