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Studies Show Biotronik’s ProMRI Pacemakers Safe in MRI Procedures

February 19, 2015

German cardiovascular devicemaker Biotronik said two studies have confirmed the safety of its ProMRI pacemakers during MRI procedures. The results of the ProMRI and ProMRI Affirm studies, announced Tuesday, were published in the journal of the Heart Rhythm Society.

The identical U.S. and European studies tracked 226 patients with the ProMRI Evia/Entovis SR-T and DR-T pacemaker systems and Setrox/Safio S 53 cm/60 cm leads who underwent head and lower back MRI scans. Patients received an initial MRI and a one month post-MRI follow-up.

No serious adverse effects were seen in either trial and the pacing threshold and sensing amplitude changes from immediately before the MRI to the post-procedure visit were stable and unchanged, Biotronik said. Moreover, the MRI exposure had no adverse impact on either patient or pacemaker, the company said.

The trial results, along with extensive testing and simulation of the devices, provided the basis for CE mark approval, said Wolf Ruhnke, vice president of Biotronik. The ProMRI pacemakers are still investigational in the U.S. — Kellen Owings