BIOTRONIK, INC. Announces First US Implant of Next-Generation Amvia Edge Pacemaker

BIOTRONIK, a leader in implantable medical device technology, today announced its first US implantation of the new Amvia Edge pacemaker. The procedure was successfully completed by Dr. Raul Weiss at Mount Sinai Medical Center in Miami, Florida.

Amvia Edge is BIOTRONIK’s next-generation pacemaker family, featuring MRI Guard 24/7, the market’s only dedicated, always-on MRI sensor. MRI Guard 24/7 is designed to allow a clinic to substantially reduce the time burden of device management for MRI scans by automatically recognizing when the patient enters an MRI field and converting the device to MRI mode. The device then automatically returns to its permanent programming following the completion of the scan, eliminating any pre- or post-scan programming needs.^1,2

Amvia Edge is the first pacemaker family from BIOTRONIK to offer EarlyCheck, another tool designed to simplify clinic workflow by automating pre-discharge checks. EarlyCheck will automatically deliver a device report and IEGM to the BIOTRONIK Home Monitoring Service Center two hours after implant, eliminating the need for an in-person device interrogation.

“I was very pleased to have been a part of the first implant of Amvia Edge. The procedure went well, and I’m excited about the benefits this new device will be able to bring to our patients as well as our practice,” said Dr. Weiss. “The ability to eliminate device scans before and after an MRI procedure is a much needed advancement, and I look forward to seeing how these types of technologies help streamline our workflows in the future.”

Additionally, Amvia Edge also offers Atrial ATP (aATP), providing multiple, automatic therapies in response to detected stable atrial arrhythmias, which may reduce atrial tachycardia burden and consequently help avoid atrial remodeling.^3,4

“I’m so pleased to hear about Dr. Weiss and his team’s successful first implant of Amvia Edge,” said Dr. David Hayes, Chief Medical Officer, BIOTRONIK, Inc. “This new family of devices was designed to optimize workflows and therapies to benefit patients and their care teams, as well as clinicians and staff.”

References

1. Usability survey results from 24 European centers related to MRI Guard 24/7. Data on file.
2. Mullane S, Michaelis K, Henrickson C, et al. Utilization and programming of an automatic MRI recognition feature for cardiac rhythm management devices. Heart Rhythm O2. 2021; 2: 132-137.
3. Nattel S, Burstein B, Dobrev D. Atrial remodeling and atrial fibrillation: mechanisms and implications. Circ Arrhythm Electrophysiol. 2008; 1(1): 62-73. 
4. BIOTRONIK data on file. 

About BIOTRONIK

At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in more than 100 countries.