FDA Approves Biotronik’s Amvia Edge Pacemakers

Biotronik has gained U.S. Food and Drug Administration (FDA) approval for its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P).
 
According to the company, Amvia Edge is the market’s smallest single-chamber, MR conditional pacemaker. Amvia Edge pacemakers tout Biotronik’s MRI Guard 24/7 tech, which uses always-on, dedicated sensors to automatically recognize when a patient enters the MRI field and converts the device to MRI mode.
 
The device then returns to its permanent programming after the scan is completed, removing the need for pre- or post-scan programming.
 
“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,” Dr. David Hayes, chief medical officer of BIOTRONIK Inc. told the press. “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.”
 
Amvia Edge devices also feature Atrial ATP (aATP), which provides multiple, automatic therapies in response to detected stable atrial arrhythmias. Other new tools automate key tasks like pre-discharge checks. An EarlyCheck feature automatically sends a device report and IEGM to the Home Monitoring Serice Center two hours after implantation to remove the need for in-person device interrogation.
 
“Amvia Edge represents BIOTRONIK’s continued commitment to healthcare professionals to help them serve their patients,” said Ryan Walters, president, BIOTRONIK, Inc. “The clinical treatment options and built-in efficiencies of Amvia are designed to solve everyday challenges for patients, physicians, and caregivers.”