Biotronik has announced that the first patients have been enrolled in an expansion of its ongoing ProMRI trial. The aim of the study is to evaluate the safety and effectiveness of the company’s pacing systems in patients undergoing full-body MRI-phase A evaluated the safety of the systems during magnetic resonance imaging (MRI) scans with exclusion zones of the chest area and Phase B will now evaluate the safety of these pacemaker systems during MRI scans including cardiac or thoracic spine scans.
A press release reports that the ProMRI clinical study aims to determine whether device patients can safely undergo full-body MRI scans. The study will recruit and evaluate 245 patients at 35 US investigational centres. 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 leads during a MRI scan. Both devices are commercially available, but still await FDA approval for use in the MRI environment.
“We are excited that Phase B of the ProMRI study has started so quickly,” said Kevin Mitchell, vice president of clinical studies at Biotronik. “There are currently limited options allowing MRI scans of the thoracic region, so our clinical sites are very enthusiastic about this new phase of the trial.”