Medtronic gains EU approval for world's first MRI-safe pacemaker

4 December 2008

Medtronic, Inc., (NYSE: MDT) announced it has received the CE (Conformité Européenne) mark for the first-ever MR-conditional pacemaker system, the EnRhythm MRITM 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% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.

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.

Bookmark this page

To top