BERLIN, Germany, February 17, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that its ProMRI and ProMRI AFFIRM studies have been published in Heart Rhythm, the official journal of the Heart Rhythm Society. The results validate the safety testing of BIOTRONIK’s ProMRI®
technology, further cementing the company as the world’s leading manufacturer of MRI conditional cardiac devices.Historically, device patients have been contraindicated for MRIs, which are the gold standard for soft tissue diagnostics and avoid the radiation risks of computed tomography (CT) scans. ProMRI systems are approved as MR conditional and enable access to this technology for the growing number of patients requiring an MRI.The results of these prospective, multi-center studies provided yet more evidence regarding the clinical safety of BIOTRONIK’s ProMRI Evia/Entovis SR-T and DR-T pacemaker systems with Setrox/Safio S 53 cm/60 cm leads, when used in head and lower lumbar 1.5 T MRI scanning.These systems have already been approved for use in CE regions based on comprehensive testing and computer simulations covering many thousands of possible imaging scenarios.The ProMRI (US) and ProMRI AFFIRM (Europe) studies were of identical design and enrolled 272 patients at 37 sites from October 2012 to November 2013. Device interrogation was performed at enrollment, pre- and post-MRI scan, and one- and three-months post-MRI. A total of 226 patients who completed the MRI and one-month post-MRI follow-up were included in the analysis.The combined studies saw no serious adverse device effects (SADE) observed. The pacing threshold and sensing amplitude changes from immediately before the MRI to the one-month post-MRI visit were stable and unchanged. There was no evidence of adverse impact on either the patient or the pacemaker system caused by MRI scanning.“The results confirm the safety and reliability of BIOTRONIK’s ProMRI devices in clinical practice,” commented author of the study Dr. William M. Bailey, Louisiana Heart Rhythm Specialists, Lafayette, LA, US. “MRIs are now a fairly common diagnostic tool and the likelihood that cardiac implantable electronic device (CIED) patients will require one at some point increases with the aging population. ProMRI devices are therefore the obvious choice for physicians and patients alike,” he continued.“The results of these studies are consistent with the extensive testing and simulation of these devices as part of the data collected to receive CE approval,” added Wolf Ruhnke, Vice President of BIOTRONIK. "With our investment in ProMRI technology and the body of evidence to prove its safety, physicians can confidently decide to perform a needed MRI scan on these patients. We believe that in the future, no cardiac device patient will be hindered from receiving this valuable diagnostic tool.”
- Investigational Device: Limited by US law to investigational use.