Biotronik studies confirm safety profile of ProMRI technology

Biotronik has announced the publication of new data from its latest ProMRI and ProMRI Affirm studies, which confirm the compatibility of the company's medical technology with magnetic resonance imaging (MRI) scans.

Published in the medical journal Heart Rhythm, the ProMRI and ProMRI Affirm studies were of identical design and enrolled 272 patients at 37 sites from October 2012 to November 2013 and aimed to validate the safety testing of the firm's ProMRI technology.

Typically, medical device patients have been contraindicated for MRIs due to the risk of interference, but these two studies showed that Biotronik's ProMRI-equipped devices were associated with no serious adverse device effects observed.

The pacing threshold and sensing amplitude changes from immediately before the scan to the one-month post-MRI visit were stable and unchanged, with no evidence emerging of an adverse impact on either the patient or the pacemaker system.

Wolf Ruhnke, vice-president of Biotronik, said: "With our investment in ProMRI technology and the body of evidence to prove its safety, physicians can confidently decide to perform a needed MRI scan on these patients."

This comes after the company completed a new study of its Entovis pacemakers at the end of last year, evaluating the effectiveness of their ProMRI technology.