KG,
I don't know if Medtronic is the only company working on this,
but here is some more information about the technology:
Friday March 14 5:02 PM EDT
New Medtronic Therapy for Disabling Tremor Recommended by FDA
Advisory Committee
MINNEAPOLIS, March 14 /PRNewswire/ -- Medtronic Inc today announced that 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).
"We hope the FDA will act on the panel's recommendation as quickly as possible to make Medtronic's Tremor Control
Therapy available for the thousands of Americans with disabling tremor," said Michael M. Selzer, Jr., vice president and
general manager of Medtronic's Neurostimulation business. "Nearly 2,000 people in Canada, Europe and Australia already
are experiencing the benefits of Activa Therapy in managing a debilitating condition that affects almost everything they do in
their daily lives. We believe Activa Tremor Control Therapy will meet a significant unmet medical need in the U.S."
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 the world's leading medical technology company, specializing in
implantable and invasive therapies. The Medtronic Internet address is medtronic.com. SOURCE Medtronic,
Inc. |
