|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 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.
About Medtronic Neurostimulation Therapy for Chronic Pain
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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 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 World Bank population data http://data.worldbank.org/indicator/SP.POP.TOTL and OECD health data http://www.oecd.org/health/healthpoliciesanddata
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