CE mark for pacemaker series with event-triggered IEGM transmissions


Biotronik announced CE mark approval for its new Eluna pacemaker series. The new generation of pacemakers includes single and dual-chamber as well as cardiac resynchronisation (CRT-P) devices. According to a company release, the first implantations are currently taking place worldwide.

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 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% of pacemaker patients suffer from atrial fibrillation, a type of atrial tachyarrhythmia that can be difficult to detect due to its silent nature, continuous and reliable monitoring is crucial.

“The new Biotronik pacemaker series is truly a step forward in terms of reliability and patient security,” comments Hendrik Bonnemeier 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.”

The new Biotronik device family features ProMRI full-body scan in the single and dual-chamber pacemakers, and ProMRI capability in the CRT-P devices, enabling patients to undergo crucial MRI scans on nearly every part of the body.