Medtronic Introduces The First And Only Neurostimulation Systems With CE Mark Approval For Full-Body MRI Scans

Date: Feb-01-2013Medtronic, Inc. (NYSE: MDT)
have 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® MRI
leads include: RestoreSensor® SureScan® MRI, PrimeAdvanced® SureScan MRI,
RestoreAdvanced® SureScan MRI, and RestoreUltra® 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 In Western Europe alone, 29 million scans
were performed in 2010, with the number of scans doubling every five years.2

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® II programmable drug infusion system and the
Advisa DR MRI™ SureScan® pacing system available outside the U.S. In the U.S , such devices
include the Medtronic SynchroMed® II programmable drug infusion system and the Revo MRI®
SureScan® pacing system which are safe for MRI access to any region of the body when
positioning guidelines are followed.

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.