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World’s First Deep Brain Stimulation Device Approved for Treatment of Psychiatric Condition in Europe

July 14, 2009

TOLOCHENAZ, Switzerland, July 14 /PRNewswire-FirstCall/ –

– CE Mark Approval for Medtronic’s Reclaim(R) DBS Therapy for Treatment
of Chronic, Severe Obsessive-Compulsive Disorder

Medtronic today announced that Reclaim(R) Deep Brain Stimulation (DBS)
Therapy has received CE (Conformite Europeene) Mark approval for the
treatment of chronic, severe treatment-resistant obsessive-compulsive
disorder (OCD).* This is the first time that a deep brain stimulation therapy
has gained approval in Europe for the treatment of a psychiatric disorder.

Following CE Mark approval, Medtronic will conduct a multi-national
post-market study to commence in at least eight sites in Europe. In addition
to following any adverse events associated with the therapy, the study will
further evaluate improvements seen in OCD symptoms as assessed by the
Yale-Brown Obsessive Compulsive Scale (Y-BOCS), before deep brain stimulation
to 12 months after.

Professor Loes Gabriels from the Catholic University of Leuven, Belgium,
and lead investigator of the post-market study comments: “For patients with
severe OCD who have tried and failed treatment through the treatment
algorithm, DBS could result in a significant improvement of a disease that
severely impacts on their lives. This study will be important in reinforcing
the evidence base of DBS in the treatment of psychiatric conditions.”

European centres first pioneered the technique of deep brain stimulation
and the Catholic University of Leuven in Belgium was a leading contributor to
the clinical evidence which was used to obtain CE mark approval in Europe as
well as FDA approval in the United States (obtained in February 2009 through
a humanitarian device exemption).

Previous research into DBS therapy for OCD, recently published in the
journal Molecular Psychiatry, revealed clinically meaningful symptom
reductions and functional improvement in about two-thirds of patients and
demonstrated that a majority of patients moved from a severe OCD rating at
the start of the study to a mild or moderate rating at various follow-up
points after device implantation.

The studies also highlighted the importance of a multidisciplinary
approach to treating OCD with deep brain stimulation therapy.

Prof Nuttin, neurosurgeon at the Catholic University of Leuven in Belgium
comments: “It is clear that for the best results a multidisciplinary team
consisting of a psychiatrist and neurosurgeon plus several other important
specialties must be involved when selecting, treating and managing the
long-term follow-up for a patient who undergoes deep brain stimulation for
OCD.”

OCD affects 2 percent of the population and it is estimated that for
patients with chronic, severe treatment-resistant OCD, more than 1,000
patients per year could benefit from Reclaim DBS Therapy for OCD in Western
Europe
. Patients with severe OCD, as defined by a Y-BOCS score over 30, and
who have tried at least three selective serotonin reuptake inhibitors (SSRIs)
without treatment success, may be considered eligible for Reclaim DBS therapy.

The neurostimulators used for Reclaim DBS Therapy are the same as those
used to treat common movement disorders like Parkinson’s disease and
dystonia. However, because the area of the brain targeted for OCD is
different, a unique DBS lead has been specially designed by Medtronic.

“Deep brain stimulation therapies were pioneered by Medtronic
neuromodulation and to date, with more than 20 years of experience, 60,000
people worldwide have benefited from Medtronic DBS therapy for Parkinson’s
disease, essential tremor and dystonia,” said Karl Schweitzer, vice president
for Medtronic’s Neuromodulation business in Europe. “This approval marks the
world’s first steps into DBS for Psychiatric disorders and demonstrates how
Medtronic continues to lead the way in research, therapy indication
expansion, and technology.”

*Medtronic Reclaim DBS Therapy is indicated for bilateral stimulation of
the anterior limb of the internal capsule, AIC, as an adjunct to medications
and as an alternative to anterior capsulotomy for treatment of chronic,
severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult
patients who have failed at least three selective serotonin reuptake
inhibitors (SSRIs).

About Reclaim DBS Therapy

Reclaim DBS Therapy is an adjustable, reversible and non-drug therapy
that uses a surgically implanted medical device, similar to a pacemaker, to
deliver carefully controlled electrical pulses to precisely targeted areas of
the brain. The stimulation can be programmed and adjusted non-invasively
(without surgery) by a trained clinician to find the most appropriate type
and amount of stimulation for each patient to maximize symptom control and
minimize side effects.

For OCD and treatment-resistant depression; a further psychiatric
disorder which Medtronic is currently exploring with Reclaim DBS therapy in a
multi-center randomized clinical trial; the anatomical target in the brain is
the anterior limb of the internal capsule (AIC), and more specifically, a
region sometimes referred to as the ventral capsule/ventral striatum (VC/VS),
which is a central node in the neural circuits believed to regulate mood and
anxiety.

About OCD

People with OCD have persistent, upsetting thoughts (obsessions) and use
rituals (compulsions) to control the anxiety these thoughts produce. If OCD
becomes severe, it can keep a person from working or carrying out normal
daily activities. Standard treatments such as medications and cognitive
behavioral therapy (CBT) fail to work for a subset of people with OCD.

Medtronic’s Leadership in DBS for Psychiatric Disorders

Medtronic has been pursuing research of DBS for psychiatric disorders for
more than a decade in collaboration with physicians from many leading
institutions. The company holds several patents related to the technologies
used in DBS as well as the use of DBS for psychiatric disorders, including
for treatment-resistant depression and OCD. To date, all peer-reviewed
publications about DBS for psychiatric disorders, including
treatment-resistant depression, have been based on the use of Medtronic DBS
systems.

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 Annual Report on Form 10-K for the
year ended April 24, 2009. Actual results may differ materially from
anticipated results.

    Contacts:

    Jeff Warren
    Investor Relations
    +1-763-505-2696

    Jon Pike
    Public Relations
    +44-1923-205-128

SOURCE Medtronic, Inc.


Source: newswire