The FDA approved a pacemaker system that allows the patient to undergo MR imaging scans with a limited exclusion zone.
Biotronik announced that it received FDA approval for its Entovis pacemaker system with ProMRI technology. The approval applies to single- and dual-chamber pacemakers implanted with Setrox leads. The devices were already commercially available in the U.S. but not approved for use in the MRI environment.
The FDA based its decision on a clinical study that was expanded to include full-body MRI scans. These studies evaluated the safety and efficacy of existing single- and dual-chamber Entovis pacemaker systems and Setrox 53 and 60cm leads during MRI scans.
Berlin-based Biotronik also is evaluating its ProMRI technology in implantable cardioverter-defibrillator devices.