Biotronik has announced that the US Food and Drug Administration (FDA) has granted approval for its Entovis pacemaker system with ProMRI technology. The Entovis system allows patients to undergo magnetic resonance imaging (MRI) scans with a limited exclusion zone. FDA approval covers both single chamber (SR-T) and dual chamber (DR-T) Entovis pacemakers when implanted with Setrox pacing leads.
“With the Entovis longevity and the history of lead reliability, this is a system that will serve a wide variety of pacemaker patients for the foreseeable-and unforeseen-future needs,” says Carleton Nibley, electrophysiologist at John Muir Medical Center in Concord and Walnut Creek, California, USA, and a participant in the ProMRI study.
The Entovis system presents advantages over existing pacemakers approved as MR conditional. Patients with approved Entovis pacemakers and leads need only alert radiology staff of their device and the staff will verify the patient meets the criteria to undergo an MRI scan.
FDA approval comes only 16 months after the initial clinical study was launched, and five months after the approval of that study’s expansion to include full-body MRI scans. These studies are required by FDA for product evaluation, and are designed to assess the safety and efficacy of Biotronik’s existing single- and dual-chamber Entovis pacemaker systems and Setrox 53 and 60cm leads during MRI scans. These devices are already commercially available in the USA, but lacked FDA approval for use in the MRI environment.