Biotronik, a manufacturer of cardiovascular medical devices, has enrolled the first patients in an expansion of its ongoing ProMRI trial, designed to determine whether device patients can safely undergo full-body MRI scans.
Earlier in November 2013, the company had completed Phase A of the study, which was designed to evaluate the safety of current Biotronik pacemaker systems during magnetic resonance imaging (MRI) scans with exclusion zones of the chest area.
Now, Phase B will evaluate the safety of these pacemaker systems during MRI scans including cardiac or thoracic spine scans, the company reported.
The study will recruit and evaluate 245 patients at 35 US 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 leads during a MRI scan.
Both devices are commercially available, but still await FDA approval for use in the MRI environment.
Biotronik vice president of clinical studies Kevin Mitchell said the company is excited that Phase B of the ProMRI study has started so quickly.
"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," Mitchell added.