FDA approves Medtronic's 'brain pacemaker' for Parkinson
Terry Fiedler
Star Tribune
Published Jan 15 2002
Parkinson's disease patients who have been robbed of their
ability to walk, talk or dress themselves have a new treatment
option.
Fridley-based Medtronic Inc. got the go-ahead Monday from
the Food and Drug Administration to market its Activa
implanted electrical brain stimulation device for advanced
Parkinson's disease.
"It's a unique product and a long-awaited approval," U.S.
Bancorp Piper Jaffray analyst Thomas Gunderson said. "It's a
welcome benefit to people with no other choices left to them."
This is the second time in the past few days that Medtronic's
neurological and spinal division, which accounts for about a
quarter of the company's $6 billion in annual revenue, has
gotten good FDA-related news.
Last Thursday, a panel of experts recommended that the FDA
approve the company's InFuse genetically engineered bone
graft product for use in spinal fusion therapy.
Activa, which the company refers to as a "brain pacemaker"
because the technology is similar to that used in cardiac pacing,
is targeted to patients who still respond to the drug levodopa
but whose symptoms are not adequately controlled by
medication.
That group includes about 100,000 patients with advanced
stages of Parkinson's out of the 1 million in the United States
who have the disease.
Activa was found to relieve the debilitating slowness, stiffness
and shaking related to the disease. It can reduce the duration of
dyskinesia, the involuntary, abnormal movements that are a
common side effect of medications used for Parkinson's.
"Activa Therapy is a major breakthrough in the treatment of
Parkinson's disease because, up until this point, patients relied
on medications such as levodopa that over time may not
provide control of symptoms and that may, in fact, produce
significant side effects," said Dr. William Marks Jr., medical
director of the Center for Parkinson's Disease & Movement
Disorders at the San Francisco Veterans Affairs Medical
Center.
The Activa device has been FDA-approved for use to control
Essential Tremor, a less debilitating disease, since 1997, and for
Parkinsonian tremor.
Prudential Financial analyst Sandra Hollenhorst called it
"truly a life-altering therapy" that, over the years could
develop into a "$1 billion market opportunity" for Medtronic.
The Activa device and related surgery will cost $50,000 to
$60,000 per patient.
Gunderson said the approval opens up another promising
market for a company that has been rapidly diversifying.
Medtronic, long known for pacemakers, recently acquired
companies that treat diabetes and prostate disease to go along
with an array of offerings for conditions other outside the
heart.
Medtronic does not have direct competition in neurology from
its main rivals, Indianapolis-based Guidant Corp. and Little
Canada-based St. Jude Medical Inc.
A panel of outside experts recommended Activa's approval for
Parkinson's in March 2000, but the FDA took about four times
as long as with some implanted heart devices to follow that
recommendation with an approval.
In the interim, several U.S. medical centers began using Activa
for Parkinson's symptoms because they considered it effective.
Hollenhorst said the FDA was especially cautious because the
treatment involves brain surgery and a first-of-its-kind
device.
The cause of Parkinson's is unknown, but the symptoms stem
from the degeneration of brain cells that produce dopamine,
the neurotransmitter that enables communication among the
brain cells involved in motor control.
The Activa system includes two power packs that are
implanted under the skin near the collar bone and two wires
that run under the skin from the packs to two electrodes
inserted deep into the brain.
The electrical pulses delivered through the electrodes
apparently disrupt the brain signals that cause the impairment
of motor skills.
-- Terry Fiedler is at tfiedler@startribune.com .
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