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FDA Recommends Approval of Medtronic Deep Brain Stimulation Therapy03/17/2010
MINNEAPOLIS – MARCH 12, 2010 – The U.S Food and Drug Administration (FDA) Neurological Devices Panel today voted to recommend approval with conditions of Deep Brain Stimulation (DBS) Therapy for Epilepsy from Medtronic, Inc. 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,” 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.”
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