Initial Safety and Efficacy Data on Allowing MRIs for Pacemaker Patients

Initial safety and efficacy data on Medtronics’ investigational implantable device—the ENRhythm MRI™—were presented August 31 at the European Society of Cardiology Conference. An ongoing study hopes to find a solution for patients with pacemakers who also require the diagnostic benefits of an MRI (magnetic resonance imaging) scan. Results presented showed no MRI-related interference complications, and no arrhythmia or asystole (absence of electrical activity in the heart) during MRI scans conducted on patients as part of a worldwide clinical study. Additionally, other study endpoints indicated that the heart responded appropriately to the level of electrical stimulation it received from the device. A small number of patients experienced implant complications consistent with rates for other pacemaker implant procedures, but none were related to the MRI technology. The trial is a prospective, randomized, controlled, un-blinded, multi-center study, involving 470 individuals; eligibility is based on the clinical indication for pacemaker implantation and a willingness and ability to undergo elective MRI scanning. Look for additional details on the Medtronics’ website. Shielding an MRI unit is a challenge in today’s health facilities. If you’ve encountered shielding challenges or you have some insights to share, be sure to go to the Interference Technology Shielding Forum.