World’s First Pacemaker Series with Event-Triggered IEGM Transmissions Gains CE Mark

BERLIN, Germany, March 27, 2014—BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced CE approval for its new Eluna pacemaker series today. The new generation of pacemakers includes single and dual-chamber as well as cardiac resynchronization (CRT-P) devices. The first implantations are currently taking place worldwide, marking yet another step forward in quality for a company that has perfected the design and engineering of its products for over 50 years.

With unique event-triggered IEGM transmissions, the new BIOTRONIK pacemaker series innovates advanced patient monitoring and allows physicians to receive an IEGM along with a notification if atrial fibrillation (AF) occurs. By notifying physicians of clinical events quickly and reliably, patient therapy can be adapted at the earliest stage possible, preventing the worsening of a patient’s condition and the occurrence of secondary diseases. Since nearly 25 percent of pacemaker patients suffer from AF, a type of atrial tachyarrhythmia that can be difficult to detect due to its silent nature, continuous and reliable monitoring is crucial.¹ BIOTRONIK Home Monitoring^® is proven to have the most reliable data transmission rates yet.²

“The new BIOTRONIK pacemaker series is truly a step forward in terms of reliability and patient security,” commented Hendrik Bonnemeier, MD, of the University Clinic Schleswig-Holstein, Kiel, Germany. “Its unique ability to transmit automatic, event-triggered IEGMs really helps me deliver the best therapy, letting me know immediately if something happens to the device or patient post-implantation. The sooner I know, the sooner I can react, and that may save my patient’s life.”

1. ^{Funck et al., Europace (2014), 16(3): 354-362.}
2. ^{Varma et al., Europace (2011), 13(3).}
3. ^{IN-TIME study results were presented in Sept. 2013 at the European Society of Cardiology conference.}