Biotronik, a manufacturer of cardiovascular medical devices, has obtained the US Food and Drug Administration (FDA) approval for Phase B of the company’s ongoing ProMRI clinical trial.
Biotronik has recently completed Phase A of the ProMRI clinical trial, which evaluated the safety of the company’s current pacemaker systems during magnetic resonance imaging (MRI) scans excluding chest and thorax scan areas.
Phase B of the trial will assess the same pacemaker system during MRI scans without exclusion zones.
Biotronik clinical studies vice president Kevin Mitchell noted removal of the exclusion zone criteria for Phase B of this trial is important because the company is now able to conduct heart or liver scans as well.
"This will significantly increase the number of patients interested in study participation, thereby accelerating our progress," Mitchell added.
Entovis devices incorporate Biotronik Home Monitoring technology that provides daily monitoring of the patient’s device and are renowned for their ability to provide the most advanced physiological therapy available through Biotronik Closed Loop Stimulation.
The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to provide excellent handling and stable fixation, and also optimal electrical performance.