New treatment for severe tremors
Ron Reiner
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New Medtronic Therapy for Disabling Tremor
Recommended by FDA Advisory Committee
Source: PR Newswire
MINNEAPOLIS, March 14 /PRNewswire/ via Individual Inc. -- Medtronic,
Inc. (NYSE: MDT) 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 http://www.medtronic.com.
SOURCE Medtronic, Inc.
/CONTACT: Investor Relations: Dale Beumer, 612-574-3038; Christopher
O'Connell, 612-574-4971; Public Relations: Jessica Stoltenberg,
612-574-3333, all of Medtronic, Inc./ (MDT) [03-14-97 at 17:02 EST, PR
Newswire]
