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Hi again, And thanks for the warm
welcome back from so many of my old friend here on the list.
I was down and not getting mail again today due to
a bad disk sector which included my registry. But all is ok
now.
MARJORIE i WAS IN FORT Lauderdale. My Mother lives
in Coconut Creek and I was there for the 90th Birthday Party of her
sister. Sorry we didn't think of getting together sooner
rather than later.
Charlie
What follows is a Medtronics Press release:
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), today announced that its Activa(R) 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 Activa(R)
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. | 