Biotronik receives FDA approval for next-generation family of pacemakers

Biotronik announced FDA approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P), its latest innovation in cardiac rhythm management.

Amvia Edge, the market’s smallest single-chamber MR conditional pacemaker, introduces a unique set of patient-centric clinical solutions coupled with automated workflow efficiency. Amvia Edge pacemakers feature Biotronik’s proprietary MRI Guard 24/7 technology, which uses always-on, dedicated sensors to automatically recognize when a patient enters an MRI field and then converts the device to MRI mode. The device returns to its permanent programming following the completion of the scan, eliminating any pre- or post-scan programming needs.

MRI Guard 24/7 is a solution for real-world challenges, as we strive to improve safety and increase efficiencies for CIED patients who need MRI access,” said Dr. David Hayes, Chief Medical Officer, Biotronik, Inc. “An MRI scan should be as easy as possible for patients, but also for caregivers in the device clinic and the MRI suite. MRI Guard 24/7 avoids repeat visits to the clinic for pre- and post-programming, and because the device only switches to MRI mode during the scan itself, it minimizes any potential patient discomfort.”

All Amvia Edge devices also feature Atrial ATP (aATP), providing multiple, automatic therapies in response to detected stable atrial arrhythmias, which may reduce atrial tachycardia burden and help avoid atrial remodeling. Atrial tachycardia can increase a patient’s risk of stroke and heart failure , while decreasing quality of life. Alongside its MRI and atrial arrhythmia solutions, Amvia Edge offers new tools that automate key tasks, such as pre-discharge checks. With the Early Check feature, a device report and IEGM are automatically sent to the Home Monitoring Service Center two hours after implant, eliminating the need for in-person device interrogation.