Biotronik, a manufacturer of cardiovascular medical devices, has obtained approval from the US Food and Drug Administration for its Entovis pacemaker system with ProMRI technology.
The FDA approval covers both single chamber and dual chamber Entovis pacemaker systems when implanted with Setrox active-fixation pacing leads.
Featuring a flexible distal end, fractal coating, and steroid elution, the Setrox leads provides excellent handling and stable fixation, as well as optimal electrical performance.
The Entovis pacemaker system implanted patients can now undergo MRI scans with a limited exclusion zone. 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.
The FDA has approved the device based on clinical studies that evaluated the safety and efficacy of Biotronik’s existing single- and dual-chamber Entovis pacemaker systems and Setrox 53 and 60cm leads during MRI scans.
The administration’s 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.
Already commercially available in the US, Entovis pacemaker systems and Setrox leads had required FDA approval for use in the MRI environment.
Biotronik said that it is the first company in the US to offer both single- and dual-chamber pacemakers approved for use in an MRI environment. Biotronik also claims that it is the first company worldwide to offer the current generation of pacing leads with ProMRI pacemakers.
Biotronik sales and marketing executive vice president Paul Woodstock noted that the Entovis ProMRI pacemaker system is the latest example of the company’s 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," Woodstock added.
Biotronik’s Entovis devices incorporate Home Monitoring technology. This technology provides daily monitoring of the patient’s device and offers the most advanced physiological therapy available via closed loop stimulation.
Image: Biotronik’s Entovis single-chamber pacemaker with ProMRI technology. Photo: Courtesy of BusinessWire/Biotronik