Biotronik announces conclusion of full-body ProMRI pacemaker study


Phase B of Biotronik’s ProMRI study has completed patient enrolment and concluded all planned scans. This phase of the study is investigating the safety of Entovis pacemakers in patients who undergo full-body magnetic resonance imaging (MRI) scans, including cardiac and thoracic spinal scans.

The Biotronik ProMRI study consists of a series of ground-breaking MRI compatibility trials; all intended to increase cardiac device patients’ access to this diagnostic tool. Phase A of the trial resulted in FDA approval of Entovis pacemaker systems for MRI scans with an exclusion zone. Phase C, still ongoing, incorporates Iforia ICD and DX systems into the list of devices being investigated for full-body MRI scans.

“The majority of current pacemakers are not approved for use in the MRI environment due to safety concerns,” says Luba Frank, assistant professor of radiology, University of Michigan Medical Center, USA. “Completion of these trials will be an important milestone towards improving access to MRI scans and improving diagnosis and treatment of these patients.”

There are more than 6.5 million pacemaker patients worldwide, and more than one million are implanted each year. Until recently, patients with a pacemaker or ICD were denied MRI scans due to concern that the strong magnetic fields and radio waves created by an MRI could have a negative effect on both the implanted device and the patient. The ProMRI technology now offers a solution that will enable cardiac rhythm patients to have access to important MRI scanning.