Source:        www.medtronic.com
Date:            14 januari 2002

'Brain Pacemaker' Receives FDA Approval for Parkinson's Disease

When drugs alone become inadequate, Medtronic's Activa® Therapy can
improve movement control and mobility while preserving options for future
treatments.

MINNEAPOLIS –– Jan. 14, 2002–– The estimated one million Americans with
Parkinson’s disease received good news today when Medtronic, Inc. (NYSE:
MDT), announced the U.S. Food and Drug Administration’s approval of Activa®
Parkinson’s Control Therapy.

The revolutionary new treatment uses Medtronic’s “brain pacemaker”
technology to relieve the debilitating slowness, stiffness and shaking that
characterize this progressive and degenerative movement disorder, which
gradually robs patients of their independence. Activa Therapy can also
reduce the duration of dyskinesia, the abnormal, involuntary movements that
are a common side effect of medications for Parkinson’s disease.

The therapy, which delivers carefully controlled pulses of electrical
stimulation to precisely targeted areas of the brain using an implanted
medical device akin to a cardiac pacemaker, is the most significant advance
in the treatment of Parkinson’s in more than 30 years. It is intended as an
adjunctive, or complementary, treatment for the approximately 100,000
patients in advanced stages of the disease who still respond to the drug
levodopa but whose symptoms are not adequately controlled by medications.

“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 neurologist William J.
Marks, Jr., M.D., assistant professor of neurology at the University of
California, San Francisco, and medical director of the Center for Parkinson’
s Disease & Movement Disorders at the San Francisco Veterans Affairs Medical
Center. “Now we have an effective new approach to treating the disabling
symptoms of this disease.

“Because Activa Therapy is adjustable, we can provide significant symptom
relief while minimizing side effects,” Dr. Marks added. “And the therapy is
reversible, which means patients will be able to pursue new treatments that
may be developed in the years ahead.”

Based on a study sponsored by Medtronic and conducted at 18 centers in North
America, Europe and Australia, the data submitted to the FDA showed that
Activa Parkinson’s Control Therapy safely and effectively improved movement
control and mobility in patients with advanced stages of the disease, when
drugs alone proved inadequate.

Of the 117 patients whose data were verified against medical records, 73
received stimulation of the subthalamic nucleus (STN) and 44 received
stimulation of the globus pallidus pars interna (GPi). (The STN and GPi are
deep brain structures that become hyperactive in Parkinson’s disease; there
is one of each structure on both sides of the brain.) With Activa Parkinson’
s Control Therapy, symptoms improved for 56 of the 117 patients while on
medication and for 102 of the 117 patients while off medication.

In addition, “on” time –– periods of good motor function and relief from
symptoms –– improved in a subset of 64 patients with verifiable diaries,
increasing by an average of 6.7 hours in the GPi group (24 patients) and 6.1
hours in the STN group (40 patients). “On” time with dyskinesia improved as
well, decreasing by an average of 4.2 hours in the GPi group and 2.8 hours
in the STN group.

Some results of the same study were reported in the Sept. 27 issue of the
New England Journal of Medicine.

The cause of Parkinson’s is unknown, but the symptoms stem from the
degeneration of neurons (brain cells) that produce dopamine. Dopamine is a
neurotransmitter that enables communication among the brain cells involved
in motor control. Activa Therapy’s electrical stimulation acts on these
malfunctioning circuits in the brain.

In the late stages of the disease, when symptoms are at their worst,
patients often experience debilitating dyskinesia as a side effect of
Parkinson’s medication. The uncontrollable shaking and flailing that rack
their bodies can lead to avoidance of public situations and self-isolation.
Eventually, the combination of symptoms and side effects can cause patients
to become totally dependent on others for their care.

“You give up a lot more than you’d ever imagine,” said Sherry Swinford, 57,
a Parkinson’s sufferer from Pilot Hill, Calif., who began receiving Activa
Therapy in October 1999. “I couldn’t cut my own steak in a restaurant. My
right leg would shake. I’d shuffle, and people would look at me as though I’
d been drinking. The comments were terrible. I didn’t want to be seen in
public.”

“Before Sherry began Activa Therapy, we were cut off from doing a lot of
things with our friends and family,” said Mack Swinford, Sherry’s husband.
“Now we’re able to get out and enjoy ourselves a lot more.”

The approval of Activa Parkinson’s Control Therapy expands the indications
for Medtronic’s “brain pacemaker” in the United States. In July 1997, the
FDA approved Activa Tremor Control Therapy for the treatment of Essential
Tremor and Parkinsonian tremor.

In Europe, Canada and Australia, Activa Parkinson’s Control Therapy has been
available since April 1998 and Activa Tremor Control Therapy since February
1995. To date, about 15,000 people worldwide have been implanted with “brain
pacemakers” to treat their disease.

“Medtronic has the privilege of collaborating with the world’s leading
physicians and clinical researchers in developing innovative approaches to
treating neurological disorders,” said Scott Ward, president of Medtronic
Neurological and Diabetes. “Activa Parkinson’s Control Therapy is Medtronic’
s latest achievement in restorative neuroscience, and we look forward to
providing other innovative therapies for chronic diseases of the central
nervous system.”

Brain stimulation also shows promise for the treatment of other neurological
disorders. It represents one aspect of Medtronic’s focus on advancing the
study and practice of restorative neuroscience, an emerging area of medicine
that relies on neurosurgery, neurology, neurophysiology and biomedical
engineering to restore the function of the central nervous system.

Medtronic, Inc. www.medtronic.com, headquartered in Minneapolis, is the
world’s leading medical technology company, providing lifelong solutions for
people with chronic disease. People who want more information about Activa
Therapy can visit www.brainpacemaker.com or call 1-800-664-5111, ext. 1100.

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 on Form
10-K for the year ended April 27, 2001. Actual results may differ materially
from anticipated results.

Editor’s Note: Additional information and graphics related to Activa
Parkinson’s Control Therapy are available at www.activapresspage.com and
through Medtronic’s online newsroom: www.medtronic.com/newsroom.

Contact:

Rachael Scherer, Medtronic Investor Relations. 763-505-2694
Kevin Lee, Medtronic Investor Relations, 763-505-2695
Joe McGrath, Medtronic Public Relations, 763-505-2634
James Larkin, Ketchum, 415-984-2295

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