A pacemaker system enables patients to receive magnetic resonance imaging (MRI) scans with a limited exclusion zone.
Biotronik (Berlin, Germany), a manufacturer of cardiovascular medical devices, reported that the US Food and Drug Administration (FDA) has given their approval for its Entovis pacemaker system with ProMRI technology. FDA approval includes both single chamber (SR-T) and dual-chamber (DR-T) Entovis pacemakers when implanted with Setrox pacing leads.
About 50,000 single-chamber pacemakers are presently implanted in the United States on an annual basis; until today, these patients have been unable to undergo MRI scans.
Biotronik is the very first company in the United States to offer both single- and dual-chamber pacemakers approved for use in an MRI setting. In addition, Biotronik is also the first company worldwide to offer the present generation of pacing leads with ProMRI pacemakers. Setrox, including versions released under other names, is the most used lead in MRI pacemakers on the market today with over 850,000 leads sold globally.
“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 electrophysiologist at John Muir Medical Center in Concord and Walnut Creek (CA, USA), and a participant in the ProMRI study, Carleton Nibley, MD.
The Entovis system provides benefits over current pacemakers approved as MR-conditional. Patients with approved Entovis pacemakers and leads only require a dutiful radiology staff of their device and the staff will confirm the patient meets the standard to receive an MRI scan.
FDA approval came only 16 months following the first clinical study commenced, and 5 months following the approval of that study’s development to include full-body MRI scans. Such studies are demanded by the FDA for product evaluation, and are used to assess the safety and efficacy of Biotronik’s existing single- and dual-chamber Entovis pacemaker systems and Setrox 53- and 60-cm leads during MRI scans. Such devices are already commercially available in the United States, but were not yet FDA approved for use in an MRI setting.
“The Biotronik Biotronik Entovis ProMRI pacemaker system is the latest example of our commitment to excellence and meaningful innovation in supporting patient treatment and quality of life. We are proud to be able to satisfy the demand for state-of-the-art devices that allow physicians to deliver optimal care to the increasing number of pacemaker patients who may someday need an MRI," said Biotronik executive vice president of sales and marketing, Paul Woodstock.
Entovis devices include Biotronik Home Monitoring technology, which offers surveillance of the patient’s device every day, and provides the most advanced physiologic therapy accessible using closed-loop stimulation (CLS). The Setrox active-fixation pacing leads have a lithe distal end, fractal coating, and steroid elution to guarantee excellent handling and stable fixation, as well as high electrical performance.