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Friday March 31, 6:39 pm Eastern Time
Company Press Release
SOURCE: Medtronic, Inc.
FDA Advisory Committee Recommends Approval for Revolutionary Application Of Brain Stimulation to Treat Parkinson's Disease
If Approved, Medtronic Activa(R) Parkinson's Control Therapy Could be Used In U.S. to Treat All Four Major Motor Symptoms of Debilitating Neurological Disorder
MINNEAPOLIS, March 31 /PRNewswire/ -- Medtronic, Inc. (NYSE: MDT <http://finance.yahoo.com/q?s=mdt&d=t> - news </n/m/mdt.html>), today announced that its ActivaŽ Parkinson's Control Therapy, which uses bilateral brain stimulation to treat the symptoms of advanced, levodopa-responsive Parkinson's disease, received a unanimous conditional approval for marketing clearance by the Neurological Device Panel Advisory Committee to the U.S. Food and Drug Administration (FDA). Conditions include: a three-year, long-term clinical follow-up, including cognitive and neuropsychological factors; physician instruction on selecting electrodes and programming; and several recommended label changes. Medtronic does not anticipate a delay of marketing clearance based on these conditions. (Photo: <http://www.newscom.com/cgi-bin/prnh/20000224/MDTLOGO> )
If approved by the FDA, Activa Parkinson's Control Therapy would become the first new approach to treating U.S. patients with Parkinson's disease in more than 30 years. Activa Parkinson's Control Therapy is designed to treat the four major motor symptoms of Parkinson's disease: stiffness (rigidity), slowness or lack of movement (bradykinesia/akinesia), shaking (tremor) and poor balance (postural instability). While tremor is the most widely recognized symptom of Parkinson's disease, it is the combination of symptoms that makes Parkinson's disease such a debilitating condition. More than 500,000 people in the U.S. currently have Parkinson's disease, and approximately 50,000 new cases are diagnosed each year.
``Patients in the advanced stages of Parkinson's disease cannot be satisfactorily controlled with currently available therapies and as a consequence, suffer unacceptable levels of disability,'' says C. Warren Olanow, M.D., a neurologist and movement disorders specialist at Mount Sinai Medical Center in New York and a lead investigator in the clinical studies for Activa Parkinson's Control Therapy. ``Patients lose their ability to independently control their activities of daily living, and eventually, they can become completely dependent on others for their care. Brain stimulation can help improve these patients' motor function and can help improve their ability to perform their activities of daily living.''
Oral medications and irreversible surgical procedures (which destroy part of the brain) are currently the only treatments available for patients with Parkinson's disease. Oral medications, such as levodopa, can gradually lose their effectiveness over time and can induce side effects. Dyskinesia, or a series of abnormal involuntary movements, is one side effect that can be induced by oral medications.
Activa Parkinson's Control Therapy is designed to work by stimulating the structures deep within the brain that influence motor control and by blocking brain signals that cause the four major motor symptoms of Parkinson's disease. A medical device called a neurostimulator, which is similar in size to a cardiac pacemaker and implanted near the collarbone, generates mild electrical signals that are delivered to the brain via a thin implanted wire with electrodes attached to the other end. The stimulation can be adjusted non-invasively to meet each patient's needs.
In 1997, Medtronic received FDA marketing clearance for ActivaŽ Tremor Control Therapy, a unilateral therapy that uses brain stimulation to treat tremor, the only symptom of Essential Tremor and one of the four major motor symptoms of Parkinson's disease. Activa Parkinson's Control Therapy represents an extended application of this technology and has been available in Europe, Canada and Australia since 1998. It is still considered investigational in the United States.
Most side effects related to stimulation can be treated by adjusting the stimulation settings. These side effects can include slurred speech (dysarthria), abnormal involuntary movements (dyskinesia), contractions of opposing muscles (dystonia) and paresthesia. Risks associated with the surgery and device can include confusion, intracranial hemorrhage, infection, interruption of stimulation, loss of effect or lead migration.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is <http://www.medtronic.com>
Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report and Form 10-K for the year ended April 30, 1999. Actual results may differ materially from anticipated results.
SOURCE: Medtronic, Inc.