The U.S. Food and Drug Administration (FDA) has approved Medtronic's Revo MRI SureScan pacemaker specifically designed for use in MR imaging and approved under certain conditions.
Revo MRI becomes the first and only cardiac pacing system to have clearance in the U.S.
MRI procedures have been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events from exposure to powerful magnetic fields generated by MRI machines.
The FDA reviewed results from one clinical trial of 484 patients, in which 464 people were successfully implanted with the device and then randomized to receive or not receive an MRI study. None of the 211 people who underwent an MRI scan experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.
The Minneapolis-based interventional technology firm plans to begin shipping Revo MRI immediately.
