Initial safety and efficacy data recently presented at the European Society of Cardiology Congress has shown that the investigational EnRhythm MRI SureScan Pacing System from Medtronic Inc., of Minneapolis, may be a potential solution for patients receiving their first pacemaker and needing an MRI scan.
Results from the worldwide clinical study showed no MRI-related complications and no arrhythmia or asystole during MRI scans conducted on patients. Data also demonstrated that hearts responded appropriately to the level of electrical stimulation they received from the device.
According to Medtronic, 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 EnRhythm MRI SureScan System Clinical Trial is a prospective, randomized, controlled, unblinded, multi-center study involving 470 individuals. The expected study duration and follow up time is approximately 30 months. (source)