Biotronik begins phase B of expanded ProMRI trial

Biotronik has announced the commencement of patient enrolment for an expanded phase of its ongoing ProMRI trial.

The study aims to confirm the safety and efficacy of Biotronik's existing dual and single-chamber Entovis pacemaker systems and Setrox leads during a magnetic resonance imaging (MRI) scan by determining whether device users can safely undergo full-body MRI scans.

Phase A of the study evaluated the safety of current Biotronik pacemaker systems during MRI scans with exclusion zones of the chest area, and was completed in November 2013. Phase B will evaluate the safety of these systems during cardiac or thoracic spine scans.

The study will recruit and evaluate 245 patients at 35 US investigational centres. 

Kevin Mitchell, vice-president of clinical studies at Biotronik, said: "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."

Earlier this month, the company announced the EU launch of the new Passeo-18 Lux drug-releasing balloon, for use in the treatment of femoropopliteal lesions.