Biomedical device company Biotronik is highlighting clinical studies published in the journal Heart Rhythm that validate the safety of its ProMRI pacemakers in patients undergoing MR exams.
Two prospective, multicenter studies, one in the U.S. and one in Europe, enrolled 272 patients at 37 sites from October 2012 to November 2013. The studies found that Biotronik's ProMRI Evia/Entovis SR-T and DR-T pacemaker systems with Setrox/Safio S 53 cm/60 cm leads were safe when used in head and lower lumbar 1.5-tesla MR scanning (Heart Rhythm, 10 February 2015), Biotronik said.
