BIOTRONIK‘s Entovis line of single and dual chamber pacemakers have now been approved by the FDA to be safely worn by the patient while getting an MRI scan. The devices themselves have been approved previously by the FDA.
BIOTRONIK is now the only company offering both single and dual chamber MRI-compatible pacemakers in the U.S.
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.
Entovis devices include BIOTRONIK Home Monitoring® technology, which provides daily monitoring of the patient’s device, and offer the most advanced physiological therapy available via Closed Loop Stimulation (CLS). The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to ensure excellent handling and stable fixation, as well as optimal electrical performance.