European Regulators Approve Biotronik’s Eluna Pacemaker Series

Biotronik Inc., a manufacturer of cardiovascular medical technology, has received CE mark approval for its new Eluna pacemaker series, including single and dual-chamber as well as cardiac resynchronization devices.

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, the company notes. 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

“The new Biotronik pacemaker series is truly a step forward in terms of reliability and patient security,” said Hendrik Bonnemeier, M.D., of the University Clinic Schleswig-Holstein in 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.”

Numerous studies have shown that devices with Biotronik Home Monitoring aid patient therapy and significantly improve quality of life by reducing instances of hospitalization and stroke. In the In-Time study, Biotronik Home Monitoring was shown to reduce mortality in heart failure patients by more than 50 percent.²

Additionally, the new Biotronik device family features ProMRI full-body scan in the single and dual-chamber pacemakers, and ProMRI capability in the cardiac resynchronization therapy devices, enabling patients to undergo crucial magnetic resonance imaging scans on nearly every part of the body.

“If the goal of a pacemaker is to help the patient live life to the fullest, almost to the point where he forgets he has a pacemaker, then the new Biotronik pacemaker series truly succeeds,” said Daniel Gras, M.D., of the New Clinic Nantes in France. “Now that there is no longer an exclusion zone, I can diagnose any kind of comorbidity.”

“With the development of our new pacemaker series, we have once again demonstrated our commitment to excellence for life,” said Christoph Böhmer, President International at BiotronikI. “Now that remote monitoring and MR [magnetic resonance] conditional devices are highly recommended in the ESC guidelines, we are proud to say that our new pacemaker series reflects reliable and innovative care that follows these guidelines, with a longevity that is truly the best on the market.”

Those implanting the new pacemaker series include: Prof. Hendrik Bonnemeier, M.D., of the University Clinic Schleswig-Holstein, in  Kiel, Germany; Prof. Erik Friedrich, M.D., of St. Elisabeth Clinic in Saarlouis, Germany; Daniel Gras, M.D., of New Clinic Nantes in France; and Prof. Amos Katz, M.D., F.E.S.C., and Vladimir Khalameizer, M.D., of Barzilai Medical Center in Ashkelon, Israel.

References:

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