First US Patient Implanted with BIOTRONIK Eluna Pacemaker System with Full-Body ProMRI Technology

LAKE OSWEGO, Oregon, April 06, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the first US patient has been implanted with the company’s Eluna pacemaker system with ProMRI^® technology. The Eluna pacing system* allows patients to undergo full-body magnetic resonance imaging (MRI) scans.

There are more than 6.5 million pacemaker patients worldwide,¹ and more than one million more are implanted each year.² Until recently, patients with a pacemaker or implantable cardioverter-defibrillator (ICD) were denied access to MRI due to concerns that the strong magnetic fields and radio waves created by an MRI scanner could have a negative effect on both the implanted device and the patient. With its ProMRI technology, BIOTRONIK has developed a solution that will grant all cardiac rhythm patients access to vital MRI scans.

“As a physician, this is the kind of care I want to deliver to my patients,” stated Dr. Nicholas Skipitaris, electrophysiologist at Lenox Hill Hospital in New York, NY. “Patients and hospitals can be confident in the safety of MR conditional technology, which has passed Food and Drug Administration (FDA) approval. These devices will become standard of care in my practice.”

1. ^{Data on file.}
2. ^{Mond HG and Proclemer A. PACE. 2011, 34(8).}
3. ^{Manufactured by BIOTRONIK SE & CO. KG}
4. ^{Investigational Device: Limited by U.S. law to investigational use.}