FDA has approved its single- and dual-chamber Entovis pacemakers for use in MRI environments, according to Biotronik Inc.
The Lake Oswego, OR–based US subsidiary of Biotronik SE & Co. KG (Berlin) said in a press release that its Entovis pacemaker system with ProMRI technology allows patients to undergo Magnetic Resonance Imaging (MRI) scans with a limited exclusion zone. The FDA approval covers both single chamber (SR-T) and dual chamber (DR-T) Entovis pacemakers when implanted with the company's Setrox pacing leads.
Biotronik says that its Setrox pacing leads, available with its ProMRI pacemakers, are active-fixation pacing leads with a flexible distal end, fractal coating, and steroid elution. The company says these features ensure excellent handling and stable fixation, as well as optimal electrical performance. Setrox pacing leads, including versions released under other names, are, according to Biotronik, the most used leads in MRI pacemakers on the market today. Biotronik says that it has sold more than 850,000 leads worldwide.
"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," said Carleton Nibley, MD, electrophysiologist at John Muir Medical Center (Concord and Walnut Creek, CA), and a participant in the ProMRI study.
According to Biotronik, the Entovis system presents advantages over existing pacemakers approved as MR conditional. Patients with approved Entovis pacemakers and leads need only alert radiology staff that they have the device and the staff will verify that 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, required by FDA for product evaluation, were 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 were already FDA approved for sale in the United States, but lacked approval for use in the MRI environment.
The Entovis pacemaker series includes Biotronik's home monitoring technology, which provides daily monitoring of the patient's device. Biotronik says that it is the most advanced physiological therapy available via Closed Loop Stimulation (CLS).
Stephen Levy is a contributor to Qmed and MPMN.
