BIOTRONIK Reports Majority of its Pacemakers Sold Have ProMRI Technology

BOSTON, Massachusetts, and LAKE OSWEGO, Oregon, May 13, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, today announced that since the launch of the ProMRI Eluna pacemaker system in late March 2015, 60 percent of pacing devices sold by the company are approved for use during magnetic resonance imaging (MRI) scans. The announcement was made at Heart Rhythm 2015, currently underway in Boston.

“The majority of pacemaker patients are over the age of 65¹ and most are likely to have a clinical need for an MRI scan after their device is implanted,” said Dr. J. Rod Gimbel, cardiac electrophysiologist at Cardiology Associates of East Tennessee. “The pacemaker patient population typically has multiple orthopedic, oncologic, neurologic, and cardiovascular co-morbidities that are best understood with MRI; thus, it is crucial that we implant pacemakers that allow continued unfettered access to MRI.

“In my practice, I implant MRI conditional devices and leads at every opportunity to do so, as I believe MRI conditional devices are the standard of care,” added Dr. Gimbel.

Over six million people aged 65 or older undergo an MRI scan in the United States every year² and 20 percent of pacemaker patients need an MRI within the first two years of implant³. According to the Mayo Clinic, approximately 75 percent of patients who have an implantable cardiac device will need an MRI in their lifetime.^®

“Demand from physicians and patients for MRI conditional pacemakers have increased dramatically since BIOTRONIK released its complete line of ProMRI pacemakers and leads in the US. Most physicians understand the need and clinical benefits of the technology,” said Paul Woodstock, Executive Vice President of Sales and Marketing at BIOTRONIK, Inc. “Offering the most current and comprehensive products is releasing pent-up demand in the market place.”

BIOTRONIK’s ProMRI technology allows patients to undergo full-body MRI scans with both single-chamber (SR-T) and dual-chamber (DR-T) pacemakers when implanted with specially designed and thoroughly tested BIOTRONIK pacing leads. Outside the US, BIOTRONIK has the most comprehensive offering of devices and leads approved for use in MRI scans.

1. ^{Greenspon AJ, et al. Journal of American College of Cardiology. 2012, 60 (16).}
2. ^{Zhan C, et al. J Gen Intern Med. 2008, 23 Suppl.}
3. ^{SureScan Post Approval Study presented in May 2013 at Heart Rhythm Society Meeting.}
4. ^{www.mayoclinic.org, Medical Professionals, “New protocols allow for MRI in selected pacemaker patients”.}
5. ^{Investigational Device: Limited by US law to investigational use.}