BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced that Phase C of its ProMRI study completed patient enrollment in December 2014.
This phase investigates the safety of implantable cardioverter defibrillator (ICD) devices in patients undergoing full-body magnetic resonance imaging (MRI) scans. The BIOTRONIK DX system is also included in the study that investigates the effects of cardiac and thoracic spinal scans.
BIOTRONIK is one of only two companies in the US currently approved to conduct these studies, which aim to broaden diagnostic options for cardiac device patients.
The BIOTRONIK DX ICD system offers the complete diagnostic capabilities of a dual-chamber ICD, including atrial sensing and advanced proven shock reduction algorithms, with only a single lead.
DX technology was first introduced in the US in 2013 and has been adopted by electrophysiologists nationwide since then. The DX appeals to both patients, who prefer lighter implants, and physicians, who benefit from dual-chamber diagnostic information.
The BIOTRONIK ProMRI study consists of a series of MRI compatibility trials intended to increase cardiac device patients’ access to MRI. Phase A resulted in FDA approval of Entovis pacemaker systems for MRI scans with an exclusion zone.
Phase B results were submitted to the Food and Drug Administration (FDA) for approval of the Entovis and Eluna pacemaker systems for full-body MRI scans. BIOTRONIK plans on submitting data from Phase C to the FDA in 2015.
There are more than 6.5 million pacemaker patients worldwide1 and more than one million are given implants each year.2 Until recently, pacemaker and ICD patients 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 device and patient.
With its ProMRI technology, BIOTRONIK has developed a solution that will give all cardiac rhythm patients access to MRI scans.
The BIOTRONIK-sponsored trial (NCT01761162) has been in US subject recruitment since March 2013.