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FDA approves Entovis pacemaker for use during MRI

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Biotronik announced that the FDA has approved both single- and dual-chamber versions of its Entovis pacemaker system with ProMRI technology, allowing patients to undergo MRI with a limited exclusion zone.

Entovis is the first device to permit recipients of single-chamber pacemakers access to MRI scanning, according to a company press release. The FDA approval comes 16 months after the launch of the first clinical study of Entovis, and 5 months after an expansion to include full-body MRI scans in the study. The trials assessed the safety and efficacy of Entovis pacemakers during MRI scans. Entovis pacemakers already were commercially available in the United States, but were not yet approved for use during MRI.

“This is a system that will serve a wide variety of pacemaker patients for the foreseeable — and unforeseen — future needs,” Carleton Nibley, MD, electrophysiologist at John Muir Medical Center in Concord and Walnut Creek, Calif., and participant in the ProMRI study, stated in the release.