Healthcare Industry News: neuromodulation
News Release - July 16, 2009
Medtronic Files Pre-Market Approval Application for FDA Approval of Deep Brain Stimulation for Treatment-Resistant EpilepsyFDA Approval Would Represent Fifth Distinct Indication for Medtronic Deep Brain Stimulation in the United States
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ), announced it has submitted a Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for Medtronic Deep Brain Stimulation (DBS) Therapy for patients with medically refractory epilepsy with partial-onset seizures. These are patients who have uncontrollable seizures with little or no response to currently available anti-epileptic medications.
Medtronic’s PMA submission includes data from the SANTE(R) (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) prospective, randomized, double-blind pivotal clinical trial sponsored by Medtronic. The results were presented at the American Epilepsy Society meeting in December 2008. The study is still ongoing with some patients having received Medtronic DBS Therapy for more than four years.
“There is a clear need for new therapies to help patients with epilepsy who have uncontrollable seizures with little or no response to existing therapies,” said Robert Fisher, M.D., professor of neurology and director of Stanford Epilepsy Center and principal investigator for the SANTE study. “When not adequately treated, epileptic seizures can substantially impair one’s quality of life. Medtronic Deep Brain Stimulation Therapy may offer new hope for many of these individuals.”
“We are optimistic about the potential to bring Medtronic DBS Therapy to market in the United States to meet the unmet medical needs that exists in the treatment of severe epilepsy,” said Rick Kuntz, M.D., president of the neuromodulation business and senior vice president at Medtronic. “As the company that pioneered DBS therapy, we’re proud to work with leading physicians to continue the pursuit of appropriate applications for DBS therapy in chronic neurological disorders.”
According to the Epilepsy Foundation, epilepsy and seizures affect more than three million Americans of all ages, at an estimated annual cost of $12.5 billion in direct and indirect costs. About one-third of people with epilepsy cannot adequately control their seizures or tolerate other available therapies. The unpredictability of seizures affects daily activities and disrupts school days, work responsibilities and social functioning.
About Medtronic DBS Therapy
Medtronic DBS Therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver carefully controlled electrical stimulation to precisely targeted areas within the brain. The therapy is reversible and can be programmed and adjusted non-invasively (without surgery) by a trained clinician to find the most appropriate type and amount of stimulation for each patient to maximize symptom control and minimize side effects.
Medtronic DBS Therapy is currently approved by the FDA for the treatment of the disabling symptoms of essential tremor, advanced Parkinson's disease, dystonia*, and chronic, severe, treatment-resistant obsessive-compulsive disorder.* More than 60,000 people worldwide have received Medtronic DBS Therapy for these indications.
Medtronic, in collaboration with leading physicians around the world, pioneered DBS therapy and it remains the only company with a commercially available system in the United States. Medtronic’s neuromodulation business has pioneered several therapies, including electrical stimulation for chronic pain and the symptoms of overactive bladder, and implantable drug pump therapy for severe pain and spasticity. Medtronic’s neuromodulation therapies have been used by more than 400,000 patients worldwide.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 24, 2009. Actual results may differ materially from anticipated results.
* DBS therapy is approved for dystonia and obsessive-compulsive disorder under Humanitarian Device Exemptions.
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