Medtronic, Inc. : Medtronic Introduces the First and Only Neurostimulation
Systems with CE Mark Approval for Full-Body MRI Scans
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
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
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 Vectris^TM 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^(TM)
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.
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.
Medtronic, Inc. (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
- end -
1Sutton 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.
2World Bank population data http://data.worldbank.org/indicator/SP.POP.TOTL
and OECD health data
PDF summary: http://www.oecd.org/health/healthpoliciesanddata/49105858.pdf.
Both accessed: October 26, 2012.
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(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.
Source: Medtronic, Inc. via Thomson Reuters ONE
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