BIOTRONIK SE & Co.KG Reports Majority Of Its Pacemakers Sold Have ProMRI Technology

Physician and Patient Demand Validates Market Need for MRI Accessible Cardiac Implanted Devices that Facilitate Appropriate Future Care

BOSTON & LAKE OSWEGO, Ore.--(BUSINESS WIRE)--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.

“New protocols allow for MRI in selected pacemaker patients.”

“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.⁴

“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 U.S. 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 marketplace.”

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 U.S., BIOTRONIK has the most comprehensive offering of devices and leads approved for use in MRI scans.

Learn more about ProMRI at the BIOTRONIK Booth #225 at Heart Rhythm 2015.

About BIOTRONIK
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 200mm peripheral stent*; Orsiro, the industry’s first hybrid drug-eluting stent*; and the world’s first implantable cardioverter-defibrillators with ProMRI^® technology*.

*Investigational Device: Limited by U.S. law to investigational use.

For more information, visit: www.biotronikusa.com

References:

¹ Greenspon AJ et al. Journal of American College of Cardiology. 2012, 60(16).
² Zhan C et al. Journal of General Internal Medicine. 2008, Jan. 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.”