Medtronic Introduces the First and Only Neurostimulation Systems with CE Mark Approval for Full-Body MRI Scans

Wed Jan 30, 2013 8:00am EST

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TOLOCHENAZ AND MINNEAPOLIS - January 30, 2013 - Medtronic, Inc. (NYSE: MDT) today introduced in
Europe the first and only implantable neurostimulation systems indicated for use in the treatment
of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI)
scans under specific conditions.

The first new system implants have been performed by Dr. JP Van Buyten and Dr. Iris Smet in
Belgium; Dr. Rasche and Professor Tronnier in Germany; Dr. J. De Andres in Spain; Dr . K.
Gatzinsky in Sweden, and Professor Buchser in Switzerland.

Medtronic neurostimulation systems for the treatment of chronic pain recently received Conformité
Européenne (CE) Mark approval for compatibility with full-body MRI scans. Neurostimulation systems
enhanced with this technology and using VectrisTM SureScan(R) MRI leads include: RestoreSensor(R)
SureScan(R) MRI, PrimeAdvanced(R) SureScan MRI, RestoreAdvanced(R) SureScan MRI, and
RestoreUltra(R) SureScan MRI. Medtronic SureScan neurostimulation systems for the treatment of
chronic pain are not approved by the U.S. Food and Drug Administration for use in the United
States.  

"Neurostimulation therapy has become a mainstay of chronic pain management, and the introduction
of full-body, MRI-compatible spinal cord stimulation systems is an important advancement that will
help ensure neurostimulation patients have access to the diagnostic tools needed to quickly
identify potentially critical health conditions," said Dr. JP Van Buyten from the AZ Niklaas
Hospital in Belgium.

MRI scans allow physicians to make a wide range of health diagnoses by viewing highly detailed
images of internal organs, blood vessels, muscle, joints, tumors, areas of infection and more. MRI
utilizes strong magnetic fields and radio frequency pulses to create images of structures inside
the body. 

As advancements in technology have increased MRI accuracy, effectiveness and patient comfort, MRI
use has increased dramatically in recent years. It is estimated that 60 million MRI procedures are
performed worldwide each year.1 #_edn1  In Western Europe alone, 29 million scans were performed
in 2010, with the number of scans doubling every five years.2 #_edn2 

Medtronic SureScan neurostimulation systems address a significant medical need for full-body MRI
compatibility by enabling patients who are receiving Medtronic neurostimulation therapy for
chronic back and/or leg pain (also called spinal cord stimulation, or SCS) to have access to the
benefits of full-body MRI. Until now, SCS patients were denied full-body MRI scans because of
fears of the system being affected by the large magnets involved in MRI.

"Delivering systems that are compatible with a full-body MRI scan means that spinal cord
stimulation patients will not have to compromise when it comes to their healthcare, and they can
feel secure knowing that MRI is a diagnostic option," said Julie Foster, general manager and vice
president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of
Medtronic, Inc. "Medtronic's development of these systems is another example of our commitment to
advancing increasingly innovative and cost effective solutions that make it  easier for clinicians
to safely, effectively and efficiently diagnose and treat the patients they serve."

Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as
specially designed leads to reduce or eliminate the hazards produced by the MRI environment. The
devices also include a proprietary SureScan programming feature, which sets the device into an
appropriate mode for the MRI environment.

These systems are the latest additions to a growing number of Medtronic devices which are safe for
MRI access to any region of the body when used according to specified MR Conditions for Use,
including the Medtronic SynchroMed(R) II programmable drug infusion system and the Advisa DR
MRI(TM) SureScan(R) pacing system available outside the U.S. In the U.S , such devices include the
Medtronic SynchroMed(R) II programmable drug infusion system and the Revo MRI(R) SureScan(R)
pacing system which are safe for MRI access to any region of the body when positioning guidelines
are followed. 

About Medtronic Neurostimulation Therapy for Chronic Pain
Medtronic neurostimulation therapy for chronic pain uses a medical device placed under a patient's
skin to deliver mild electrical impulses to the spinal cord, which act to block pain signals from
going to the brain. Instead of pain, patients feel a tingling sensation from the neurostimulation
in areas where they had previously experienced pain. 

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 implantable neurostimulation and targeted drug delivery systems
for the management of chronic pain, common movement disorders, spasticity and urologic and
gastrointestinal disorders.  

About Medtronic
Medtronic, Inc. (www.medtronic.com http://www.medtronic.com/ ), headquartered in Minneapolis,
Minnesota, 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.

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1 #_ednref1 Sutton R, Kanal E, Wilkoff BL, Bello D, et al. Safety of magnetic resonance imaging of
patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials
2008, 9:68. 



2 #_ednref2 World Bank population data http://data.worldbank.org/indicator/SP.POP.TOTL
http://data.worldbank.org/indicator/SP.POP.TOTL  and OECD health data 
http://www.oecd.org/health/healthpoliciesanddata/OECDHealthData2012FrequentlyRequestedData_Updated.xls
http://www.oecd.org/health/healthpoliciesanddata/OECDHealthData2012FrequentlyRequestedData_Updated.xls

PDF summary: http://www.oecd.org/health/healthpoliciesanddata/49105858.pdf
http://www.oecd.org/health/healthpoliciesanddata/49105858.pdf . Both accessed: October 26, 2012.



 

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