First U.S. Patient Implanted with BIOTRONIK Eluna Pacemaker System with Full-Body ProMRI Technology

Second Generation MR Conditional Pacemakers Are the Only Offering Both Single- and Dual-Chamber Models in the U.S.

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.”

In addition to Lenox Hill Hospital, other facilities already implanting the Eluna ProMRI pacing system include:

• NYU Medical Center, New York, NY
• University of Massachusetts Memorial Medical Center, Worcester, MA
• New York Presbyterian, New York, NY
• Massachusetts General Hospital, Boston, MA
• Community Heart and Vascular, Indianapolis, IN
• Scripps Mercy Hospital, San Diego, CA
• Orlando Regional Medical Center, Orlando, FL
• Saddleback Memorial Medical Center, Laguna Hills, CA
• Sharp Grossmont Hospital, La Mesa, CA

* manufactured by BIOTRONIK SE & CO. KG

“Eluna ProMRI pacing systems are the only complete line of full-body MR conditional pacemakers with single- and dual-chamber models,” said Paul Woodstock, Executive Vice President, BIOTRONIK, Inc. “The clinical community’s strong interest in this technology validates the importance of these devices, and of providing patients and physicians with access to MRI scans.”

About Eluna
Eluna devices include wandless radio frequency (RF) telemetry for efficient device programming and interrogation at implant, the most physiologic therapy available via Closed Loop Stimulation (CLS), and HF Monitor and thoracic impedance (TI) diagnostics to provide vital information on heart failure progression. BIOTRONIK Home Monitoring^® technology available in the Eluna series is the only automatic, daily remote monitoring system for MR conditional pacing systems. Home Monitoring allows physicians to deliver the highest standard of care by efficiently managing the patient’s status through early detection of clinical episodes and device events.

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 5600 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.

References
¹ Data on file.
² Mond HG and Proclemer A. PACE (2011), 34 (8).

For more information, visit: www.biotronik.com