LAKE OSWEGO, Oregon, January 21, 2015 - BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today 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 U.S. 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 U.S. 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 U.S. subject recruitment since March 2013. The remaining patients in the study were enrolled at Massachusetts General Hospital, Boston, MA; New York University Langone Medical Center, New York, NY; Vanderbilt University Medical Center, Nashville, TN; Spectrum Health, Grand Rapids, MI; and Cardiology Center of Amarillo, TX.
- Data on file.
- Mond HG and Proclemer A. PACE. 2011, 34(8).
- Investigational Device: Limited by U.S. law to investigational use.