Phase C of Biotronik’s ProMRI study completed patient enrolment 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 USA 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 USA in 2013 and has been adopted by electrophysiologists nationwide since. Biotronik says that the DX appeals to both patients, who prefer lighter implants, and physicians, who benefit from dual-chamber diagnostic information.
The ProMRI study consists of a series of MRI compatibility trials intended to increase cardiac device patients’ access to MRI. Phase A resulted in Food and Drug Administration (FDA) approval of Entovis pacemaker systems for MRI scans with an exclusion zone. Phase B results were submitted to the FDA for approval of the Entovis and Eluna pacemaker systems for full-body MRI scans. Biotronik plans to submit data from phase C to the FDA in 2015.