First Patient Enrolled Into European Registry for Deep Brain Stimulation in Patients With Refractory Epilepsy

Minneapolis And Geneva (ots/PRNewswire) -

Milestone comes 25 years after the first DBS implant for Tremor
carried out in Grenoble, France

Medtronic, Inc. today announced that a patient from
Kempenhaeghe-Heeze (The Netherlands) is the first patient to be
enrolled into the MORE (MedtrOnic Registry for Epilepsy) Registry
which is designed to look at the long-term efficacy, quality of life
impact and safety of deep brain stimulation (DBS) in patients with
refractory epilepsy. DBS for epilepsy received CE mark for use in
Europe in August 2010. Medtronic DBS Therapy is not currently
approved by the U.S. Food and Drug Administration for use in the
United States for the treatment of refractory epilepsy.

The MORE Registry will involve approximately 200 prospective
patients over two years from more than 30 centres across Europe
including the Tampere and Tubingen Hospitals which have the most
experience to date with DBS of the Anterior Nucleus of the Thalamus.
The primary objective of the registry is to examine the impact of DBS
therapy on seizure frequency. The study will also look at seizure
type and severity, safety and impact of the therapy on a patient's
quality of life.

More than 30% of people with epilepsy fail to gain control of
seizures with antiepileptic medications.[1] These people are said to
have refractory or drug resistant epilepsy, which is defined by the
International League Against Epilepsy (ILAE) as: "the failure of
adequate trials of two tolerated and appropriately chosen and used
AED (anti-epileptic drugs) schedules (whether as monotherapies or in
combination) to achieve sustained seizure freedom".[2] Currently,
Medtronic DBS therapy is approved for use as adjunctive (add-on)
therapy for reducing the frequency of seizures in adults diagnosed
with epilepsy characterized by partial-onset seizures, with or
without secondary generalization, that are refractory to
antiepileptic medications.

The MORE registry is the latest in a long history of research
using Medtronic DBS devices including three Level 1 studies of DBS
for Parkinson's disease, [3,4,5] one Level 1 study of DBS for
Epilepsy[6] and a 10- year follow up study of DBS in Parkinson's
disease led by the University of Toronto.[7]

"The MORE registry is important in increasing our understanding
of how electrical stimulation can help patients affected by
refractory epilepsy. By studying the long-term impact of DBS on the
anterior nucleus of the thalamus, we hope to understand even further
how seizures can be controlled and reduced," said Professor Paul
Boon, Professor of Neurology at the Department of Neurology, Ghent
University Hospital in Belgium who is the chair of the steering group
behind the MORE Registry.

The commencement of the MORE Registry comes as the
neuromodulation community celebrates 25 years of DBS therapy.
Professors Benabid and Pollak performed their first DBS implant for
tremor at the University of Grenoble in January 1986.

"It is amazing to think how far we have come since the first
experimental implant of deep brain stimulation for a movement
disorder in the 1980s to today where the therapy is now approved for
conditions such as epilepsy and treatment-resistant
obsessive-compulsive disorder (OCD)," said Professor Pierre Pollak,
Head of Neurology at the University Hospital Geneva.

In Europe, Medtronic DBS Therapy has been CE mark approved for
the treatment of tremor since 1993, Parkinson's disease since 1998
and primary dystonia since 2003. The first approved implant of
Medtronic DBS was carried out in 1993. More recently, Medtronic DBS
therapy has received CE mark approval for obsessive compulsive
disorder (OCD) in July 2009 and most recently for refractory epilepsy
in August 2010.

"Working with leading physicians, Medtronic helped pioneer deep
brain stimulation, and we continue to collaborate with leading
researchers to advance DBS technology and research next-generation
therapies to treat chronic neurological conditions," said Lothar
Krinke, Ph.D., vice president and general manager for the Deep Brain
Stimulation business in Medtronic's Neuromodulation division.

About Medtronic Deep Brain Stimulation Therapy

More than 85,000 patients worldwide have received Medtronic DBS
Therapy, which uses a surgically implanted medical device, similar to
a cardiac pacemaker, to deliver mild electrical pulses to precisely
targeted areas of the brain. Electrical stimulation of these areas
normalizes the brain circuits that control symptoms. The stimulation
can be programmed and adjusted non-invasively by a trained clinician
to maximize symptom control and minimize side effects. Only the
ACTIVA family of neurostimulators provides clinicians with the
ability to deliver stimulation in constant voltage or constant
current mode, providing physicians with a choice based on their
preference and clinical needs.

Medtronic's Leadership in Neuromodulation

Medtronic developed and leads the field of neuromodulation, the
targeted and regulated delivery of electrical pulses and
pharmaceuticals to specific sites in the nervous system. The
company's Neuromodulation business includes neurostimulation and
implantable, targeted drug delivery systems for the management of
chronic pain, common movement disorders, spasticity and urologic and
gastrointestinal disorders. To date more than 500,000 people
worldwide have received Medtronic Neuromodulation therapies.

About Medtronic

Medtronic, Inc. (http://www.medtronic.com), headquartered in
Minneapolis, is the global leader in medical technology - alleviating
pain, restoring health, and extending life for millions of people
around the world.

Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic reports
on file with the Securities and Exchange Commission. Actual results
may differ materially from anticipated results.

References:

1) Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J
Med. 2000;342:314-9
2) http://www.ilae-epilepsy.org/visitors/Documents/Epigraph_Definitionofdrugresistantepilepsy.pdf
(accessed 12th September 2010)
3) Deuschl et al. A randomized trial of deep-brain stimulation for Parkinson's
disease. N Engl J Med. 2006 Aug 31;355(9):896-908.
4) Williams et al. Deep brain stimulation plus best medical therapy versus best
medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised,
open-label trial. Lancet Neurol. 2010 Jun;9(6):581-91. Epub 2010 Apr 29
5) Weaver et al. Bilateral deep brain stimulation vs best medical therapy for
patients with advanced Parkinson disease: a randomized controlled trial. JAMA. 2009
Jan 7;301(1):63-73.
6) Fisher R, Salanova V, Witt T, et al. Electrical stimulation of the anterior
nucleus of thalamus for treatment of refractory epilepsy. Epilepsia, 51(5):906-907,
2010
7) Ten-year outcome of subthalamic stimulation in Parkinson disease: a blinded
evaluation. Castrioto A, et al . Arch Neurol. 2011 Dec;68(12):1550-6. Epub 2011 Aug

ots Originaltext: Medtronic, Inc.
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