Medtronic Gets CE Mark for MRI-Compatible Pacemaker
November 17, 2008 - Medtronic received European CE Mark for the EnRhythm MRI SureScan Pacemaker System, a pacemaker designed for safe use in Magnetic Resonance Imaging (MRI) systems.
The Medtronic EnRhythm MRI SureScan pacing system is reportedly the first pacemaker and lead system to be designed and tested in patients for safe use in MRI systems under specified conditions. Commercially available in Europe and under clinical evaluation in the U.S., the pacing system consists of the newly designed dual-chamber Medtronic EnRhythm MRI SureScan pacemaker and CapSureFix MRI SureScan pacing leads (Model 5086MRI).
Each year, approximately 1 million people worldwide are implanted with a pacemaker, hundreds of thousands of whom may be able to benefit from an MRI scan. A study published in Circulation shows that an MRI procedure is requested by a physician for 17 percent of pacemaker patients within 12 months of device implant. Every three minutes in the U.S. and every six minutes in Europe, a patient is denied an MRI scan due to the presence of an implantable cardiac device.
Medtronic believes that MRI safety and accessibility for people who have these devices remains a serious concern. To achieve true safety in an MRI environment, Medtronic believes that an entire system, including the pacemaker and leads, must be designed and rigorously tested for safe use with MRI scanners, and then approved by regulatory authorities for commercial use.
For more information: www.medtronic.com