Healthcare Industry News: CapSureFix
News Release - November 17, 2008
Medtronic Receives European Approval for World’s First Pacing System Designed, Tested and Approved for MRI
EnRhythm MRI SureScan Pacemaker System Now Commercially Available in EuropeMINNEAPOLIS – Nov. 17, 2008 - (HSMN NewsFeed) – Medtronic, Inc., (NYSE: MDT) announced it has received CE (Conformité Européenne) Mark for the first-ever MR-Conditional pacemaker system, the EnRhythm MRI™ SureScan™ pacemaker and CapSureFix MRI™ SureScan™ pacing leads (Model 5086MRI). The new system was designed, tested and approved for use with magnetic resonance imaging (MRI) under specified scanning conditions, and is now commercially available in select European countries. Patients receiving the EnRhythm MRI SureScan Pacing System will for the first time be able to undergo MRI scans under certain conditions, representing a major milestone in the evolution of implantable cardiac devices.
“MRI is an invaluable medical diagnostic tool for many common diseases and conditions that, until now, patients with implanted pacemakers have been prohibited from receiving,” said Alain Coudray, M.D., Medtronic’s vice president of the Cardiac Rhythm Disease Management business in Western Europe. “Medtronic recognizes the complex needs of today’s patient and will continue to develop advancements in pacemaker technology and other devices that allow patients to receive optimal medical care.”
Approximately 2 million Europeans have implanted pacemakers, but these patients are prohibited from receiving MRI scans, a widely practiced diagnostic method for many common diseases and conditions, because their device could interact with MRI machines, potentially affecting the device or patient safety. According to estimates, 50-75 percent of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices1.
About the EnRhythm MRI SureScan System Design
The EnRhythm MRI SureScan pacing system has undergone extensive research and design efforts to address and mitigate interactions between the pacing system and the MR environment. The system includes modified hardware to minimize the level of energy transmitted through the lead/device connection point. In addition, the new system also includes a new SureScan™ feature designed to eliminate the impact of MRI-generated electrical noise, as MRI scanners may cause traditional pacemakers to misinterpret this noise and as a result withhold or deliver unnecessary pacing therapy. The device and leads also contain radiopaque marks, viewable via X-ray, to indicate that the system is MR-Conditional, a classification indicating a medical device may be used in the MRI suite under certain conditions. The CapSureFix MRI SureScan leads are designed to decrease the risk of overheating during an MRI scan without limiting the ability to conduct therapy. Safety and efficacy data on the system presented at the recent European Society of Cardiology congress showed no MRI-related complications, and no arrhythmia or asystole (absence of electrical activity in the heart) during MRI scans conducted on patients in a worldwide clinical study.
About MRI
MRI lets doctors see internal organs, blood vessels, muscles, joints, tumors, areas of infection and more, without X-rays or surgery, and without exposing the patient to any ionizing radiation. The MRI machine creates a magnetic field, sends radio waves through the body, then measures the response with a computer, creating an image of the inside of the body. In many cases, MRI gives information that cannot be seen on an X-ray, ultrasound or computed tomography (CT) scan.
Caution: The EnRhythm MRI SureScan Pacing System is investigational and not currently available for sale in the United States. The device is limited by federal law to investigational use only.
About Medtronic
Medtronic, Inc. (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 25, 2008. Actual results may differ materially from anticipated results.
1 Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. Pacing Clin Electrophysiol. April 2005;28(4):326-328.
Source: Medtronic
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