Image courtesy of Biotronik
December 19, 2014 – Biotronik announced 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 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 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 and DX systems into the list of devices being investigated for full-body MRI scans.
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. 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 has been in U.S. subject recruitment since March 2013.
For more information: www.biotronik.com