November 17, 2008 - Medtronic Inc. said it received CE 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.
Approximately 2 million Europeans have implanted pacemakers, but these patients are prohibited from receiving MRI scans. 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 devices, Medtronic said.
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 company said. 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.
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.
The EnRhythm MRI SureScan Pacing System is investigational and not currently available for sale in the U.S..
For more information: www.medtronic.com