January 29, 2014 — Biotronik enrolled the first patients in an expansion of their ongoing ProMRI trial to test its pacemaker system.
Phase A of the study evaluated the safety of current Biotronik pacemaker systems during magnetic resonance imaging (MRI) scans with exclusion zones of the chest area, and was completed on November 18, 2013. The U.S. Food and Drug Administration (FDA) granted approval for Phase B, which will evaluate the safety of these pacemaker systems during MRI scans including cardiac or thoracic spine scans.
The ProMRI clinical study aims to determine whether device patients can safely undergo full-body MRI scans, which can have negative effects on pacemakers and patients, and are therefore contraindicated for pacemaker patients. The study will recruit and evaluate 245 patients at 35 U.S. investigational centers. The ProMRI full-body scan expansion is designed to confirm the safety and efficacy of Biotronik’s existing dual- and single-chamber Entovis pacemaker systems and Setrox 53 and 60 cm leads during a MRI scan. Both devices are commercially available, but still await FDA approval for use in the MRI environment.
Entovis devices include Biotronik Home Monitoring technology, which provides daily monitoring of the patient’s device and ability to provide physiological therapy via Biotronik Closed Loop Stimulation (CLS). The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to for handling and stable fixation, as well as electrical performance.
The Biotronik-sponsored trial has been in U.S. subject recruitment since March 2013.
For more information: www.biotronik.com