FDA Approves MRI-Safe Pacemaker Despite Medtronic Warning Letter

The FDA has approved Medtronic’s Revo as the first pacemaker designed for use during certain magnetic resonance imaging (MRI) exams, despite an unresolved warning to the company. The FDA reviewed clinical trial results from 464 patients that were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 patients who underwent an MRI experienced an exam-related complication, according to the agency. Medtronic is still working toward resolving the letter and it is unsure why the FDA approved Revo without issuing a closeout letter, company spokeswoman Wendy Dougherty told D&DL.
Devices & Diagnostics Letter