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| |  FDA Advisory Committee Recommends New Medtronic Therapy for Tremors MINNEAPOLIS, March 14 /PRNewswire/ -- A new treatment for unilateral Essential Tremor and tremor associated with Parkinson's disease was recommended unanimously for marketing clearance by the Neurological Device Panel Advisory Committee to the U.S. Food and Drug Administration (FDA). Essential Tremor is the most common neurological movement disorder in this country. The condition afflicts at least a million Americans, usually age 45 or older. Parkinson's disease, a progressive and degenerative neurological disease characterized by tremor as one of its four primary symptoms, affects approximately 500,000 people in the United States. Tremor worsens from mild to disabling at a variable rate, depending on the individual. The therapy uses an implanted device, similar to a cardiac pacemaker, to deliver electrical stimulation to block or override brain signals that cause tremor. Medtronic's new therapy allows the stimulation level to be adjusted to the needs of each patient. Potential adverse effects of the therapy can include tingling of limbs (paresthesia), slight paralysis (paresis), slurred speech (dysarthria) and loss of balance (disequilibrium). Based on the research presented to the advisory committee and submitted to FDA, adverse effects were minor and were reduced or disappeared when the stimulation was decreased or turned off. The risks associated with surgery, although infrequent, include intracranial hemorrhage. Medtronic, Inc., headquartered in Minneapolis, is a medical technology company, specializing in implantable and invasive therapies.
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