A clinical study evaluating the performance of Medtronic‘s EnRhythm MRI SureScan pacemaker has shown that the device is not subject to interference from magnetic resonance imaging. As the only pacemaker approved for MRI in the EU, the news may give the FDA enough guidance to also approve it as the first of its kind in the US.
Results showed that Medtronic’s investigational EnRhythm MRI SureScan pacing system still performs as intended during and after an MRI when used according to the product’s labeling. The data showed no MRI-related complications, and no arrhythmias, or asystole (absence of electrical activity in the heart) during MRI scans.
This prospective, randomized, controlled trial involved 464 individuals successfully implanted at 41 centers in the U.S., Canada, Europe and the Middle East. After successful implant of pacemaker and leads, 258 patients were randomized to MRI and 206 to no MRI (control). All patients were evaluated before and after the scan, and one week and one month after MRI scan/control visit. There was no difference in performance between the MRI group and the control group.