Medical Device Network

BIOTRONIK debuts pacemaker with continuous MRI sensor

The Amvia Edge pacemaker from BIOTRONIK makes its US debut following a successful implantation at Mount Sinai Medical Centre.

BIOTRONIK has successfully completed the first human implantation of its Amvia Edge pacemaker in the US. The cardiac device incorporates the use of a continuous MRI sensor and is the first from the company to use EarlyCheck, a tool designed to automate pre-discharge checks.

According to BIOTRONIK, EarlyCheck eliminates the need for in-person device interrogation by automatically sending a device report and IEGM data to the Home Monitoring Service Center within two hours of implantation.

The standout feature of the pacemaker is its continuous MRI sensor, MRI Guard 24/7. It allows the Amvia Edge pacemaker to instantly detect when a patient enters an MRI field and switches the device into MRI mode. Once the scan is complete, the pacemaker reverts to its default programming, eliminating the arduous pre- and post-scan programming steps.

The device also offers Atrial ATP (aATP) capabilities, to address stable atrial arrhythmias. aATP provides multiple automatic therapies in response to detected stable atrial arrhythmias, potentially reducing atrial tachycardia burdens and helps prevent atrial remodeling.

Dr. Raul Weiss completed the implantation of the device at the Mount Sinai Medical Center in Miami, Florida. He expressed excitement about the successful procedure.

“I was very pleased to have been a part of the first implant of Amvia Edge,” said Weiss. “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. 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.”

In 2022, around 1.5 million people around the world received a pacemaker, and GlobalData forecasts that the annual volume of pacemakers sold will reach 2.5 million pacemakers by 2033. And despite a compound annual growth rate of less than 5%, major companies continue to innovate and expand their pacemaker portfolio.

In June 2023 the company also announced it had completed the first global implant of its BIOMONITOR IV implantable cardiac monitor (ICM) with artificial intelligence (AI). Which integrates the company’s SmartECG technology with AI to lower all false positive detections.