Home Latest News Biotronik receives CE mark for Amvia Sky and Edge devices

Biotronik receives CE mark for Amvia Sky and Edge devices

Biotronik receives CE mark for Amvia Sky and Edge devices
The Amvia Pacemaker and CRT-P Family.

Biotronik announced today the latest addition to its cardiac rhythm management portfolio.

“We are excited to have received CE mark for our newest technology—the world’s first pacemakers and CRT-Ps approved for left bundle branch pacing. Amvia Sky and Amvia Edge represent cutting-edge innovation and incorporate the latest cardiology trends,” says Andreas Hecker, electrophysiologist at Biotronik. In 1963, the company introduced the first German implantable pacemaker and is continues to advance the cardiovascular market today.

Left bundle branch area pacing (LBBAP) is a relatively new, more physiologic approach in cardiac pacing. Previous studies pointed out that physiologic pacing could maintain or even improve cardiac function and improve long-term clinical outcomes compared to conventional right ventricular pacing. In a recent multi-centre study, Jan De Pooter (University Hospital Ghent, Ghent, Belgium) claims that “LBBAP using Biotronik conduction system tools is a safe and reliable treatment option. It is associated with high implant success, low pacing thresholds and high safety profile.” The Amvia family now ties in with these tools.

Alongside a range of choices for physiologic pacing, the Amvia family also offers new tools that automate tasks during implantation, in-office follow-ups and remote monitoring. Furthermore, MRI Guard 24/7, the next-generation magnetic resonance imaging (MRI) access addition, provides an automatic MRI mode switch for easy examinations without pre- and post-scan programming appointments—for the benefit of both care teams and patients. Justin Mariani (The Alfred Hospital Heart Centre, Melbourne, Australia), is leading the first in-human study of the Amvia system called BIO|CONCEPT Amvia. “The advantages of the Amvia family look very promising. The systems include several physiologic pacing and time-saving functions that will improve clinical workflows and patient care,” says Mariani. Final results of the study are expected later this year.


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