BIOTRONIK, a German firm engaged in developing implantable medical device technology, has reported the first implantation of its next-generation Amvia Edge Pacemaker in the US.
Amvia Edge is equipped with MRI Guard 24/7, which is designed to be an always-on MRI sensor.
The sensor is intended to enable clinics to significantly minimise the time burden of managing devices for MRI scans. For this, it automatically detects when the patient enters an MRI field and converts the device to MRI mode, according to the medical device firm.
BIOTRONIK said that once the scan is over, the device automatically returns to its permanent programming. This removes the need for any pre- or post-scan programming.
The maiden implant procedure in the US was conducted at Mount Sinai Medical Center in Miami, Florida by Raul Weiss.
Weiss said: “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.
“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.”
Amvia Edge, which received the US Food and Drug Administration (FDA) approval in July 2023, is the first pacemaker family from BIOTRONIK to offer EarlyCheck, a tool that streamlines clinic procedure by automating pre-discharge inspections.
Two hours after implant, EarlyCheck is said to automatically send a device report and intracardiac electrogram (IEGM) to the BIOTRONIK Home Monitoring Service Center. This removes the need for an in-person device interrogation.
Furthermore, the Amvia Edge system provides Atrial ATP (aATP) to deliver numerous automated therapies upon identifying stable atrial arrhythmias. This approach has the potential to decrease the load of atrial tachycardia and, consequently, aid in preventing atrial remodelling, the medical device firm added.
BIOTRONIK chief medical officer David Hayes said: “I’m so pleased to hear about Dr. Weiss and his team’s successful first implant of Amvia Edge.
“This new family of devices was designed to optimise workflows and therapies to benefit patients and their care teams, as well as clinicians and staff.”
