FDA panel endorses Medtronic Revo MRI pacemaker
This article was originally published in The Gray Sheet
Executive Summary
Medtronic is on track to be the first to market a pacemaker labeled for safe use with magnetic resonance imaging procedures in the U.S. following a unanimous 15-0 approval recommendation from FDA's Circulatory System Devices advisory panel March 19. The panel conditioned its approval recommendation on a post-market study to further evaluate what happens on multiple MRI scans over time, and to capture more data on the device's lead system. The advisory group also seeks training for radiology technicians who perform MRI scans so that they can identify patients with the devices and meet related scan requirements. Device labeling also should specify that the system is only MRI-safe with the appropriate pacer and lead combination, the panel said. "The results were what we needed to see" to justify FDA approval, said panel member David Naftel, Ph.D., University of Alabama, Birmingham
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