BIOTRONIK Expansion of ProMRI® Clinical Trial Receives FDA Approval

BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of their ongoing ProMRI® trial. The just-completed Phase A of the trial evaluated the safety of BIOTRONIK’s current pacemaker systems during magnetic resonance imaging (MRI) scans excluding chest and thorax scan areas. Now Phase B of the trial, just approved by the FDA, will evaluate the same pacemaker system during MRI scans without exclusion zones. Several million patients are currently implanted with pacemaker systems worldwide, and recent studies estimate that a sizeable portion of them will develop a clinical need for a MRI scan during their lifetimes.(1,2) MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography (CT), or ultrasound. The strong forces applied during MRI can have a negative effect on both device and patient, and are therefore contraindicated for pacemaker patients. The ProMRI® clinical study aims to determine whether device patients can safely undergo full-body MRI scans. The study will recruite and evaluate 245 patients implanted with one of BIOTRONIK’s latest pacemaker systems at 35 U.S. investigational centers. The ProMRI® expansion is designed to confirm the safety and efficacy of BIOTRONIK’s existing dual- and single-chamber Entovis pacemaker systems and Setrox 53 & 60 cm leads during an MRI scan. Both devices are commercially available, but lack FDA approval for use in the MRI environment. "Removal of the exclusion zone criteria for Phase B of this trial is important because we are now able to conduct heart or liver scans as well,” said Kevin Mitchell, Vice President of Clinical Studies at BIOTRONIK, Inc. “This will significantly increase the number of patients interested in study participation, thereby accelerating our progress." “The options for patients with CRM devices who need MRI scans have been very limited,” said Pamela K. Woodard, M.D., Director of the Center for Clinical Imaging Research (CCIR) at Washington University School of Medicine, St. Louis, MO. “We’ve used this new system during the clinical trial so far, and for the head and pelvis it has been nearly equivalent to the scan process for non-CRM device patients. I’m very excited to see what we can learn about its full-body capabilities.” Entovis devices include BIOTRONIK Home Monitoring® technology, which provides daily monitoring of the patient’s device and are renowned for their ability to provide the most advanced physiological therapy available via BIOTRONIK Closed Loop Stimulation (CLS). The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to provide excellent handling and stable fixation, as well as optimal electrical performance. The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. site recruitment since March 2013. About BIOTRONIK As one of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®, the world’s first 4 F-compatible 200 mm peripheral stent, Orsiro, the industry’s first hybrid drug-eluting stent, and the world’s first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology. This year BIOTRONIK celebrates its 50th anniversary. For more information, visit: www.biotronik.com 1 Morgan Stanley, ICD market, 1996–2009. 2 Roguin et al., Europace 2008, 10, 336-346.