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.
Initial Safety and Efficacy Data on Allowing MRIs for Pacemaker Patients
