Biotronik Completes Enrollment in Part B of its ProMRI Study

Biotronik, a Germany-based manufacturer of cardiovascular medical technology, has completed patient enrollment in Phase B of its ProMRI study. In addition, all planned scans have been completed, the company recently reported. 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.

Biotronik’s U.S.-based ProMRI study consists of a series of MRI compatibility trials; all intended to increase cardiac device patients’ access to this diagnostic tool. Phase A of the trial resulted in U.S. Food and Drug Administration (FDA) approval of Entovis pacemaker systems for MRI scans with an exclusion zone. Phase C, still ongoing, incorporates Iforia ICD (implantable cardioverter defibrillator) and DX systems into the list of devices being investigated for full-body MRI scans. In May, the FDA granted Biotronik permission to expand Phase C of the ProMRI trial.

“The majority of current pacemakers are not approved for use in the MRI environment due to safety concerns,” said Luba Frank, M.D., assistant professor of radiology, University of Michigan Medical Center, Ann Arbor, Mich. “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, according to figures cited by the company, and more than 1 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. Biotronik claims its ProMRI technology is a solution that will enable all cardiac rhythm patients to have access to important MRI scanning.