BIOTRONIK Announces Conclusion of Full-Body ProMRI Pacemaker Study

LAKE OSWEGO, Oregon, December 9, 2014 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that Phase B of its ProMRI^® study has completed patient enrollment 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,” said Luba Frank, MD, Assistant Professor of Radiology, University of Michigan Medical Center, Ann Arbor, MI. “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,¹ and more than one million are implanted each year.² 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. With its ProMRI technology, BIOTRONIK has developed a solution that will enable all cardiac rhythm patients to have access to important MRI scanning.

The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. subject recruitment since March 2013.

1. ^{Data on file.}
2. ^{Mond HG and Proclemer A. PACE. 2011, 34(8).}
3. ^{Investigational Device: Limited by U.S. law to investigational use.}