Biotronik has received the US Food and Drug Administration (FDA) approval for its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemakers (CRT-P).

Amvia Edge family of pacemakers are intended to provide a unique set of patient-centric clinical solutions, combined with automated workflow capabilities.

The German medical device company designed the next-generation family of pacemakers using its MRI Guard 24/7 technology.

The technology leverages always-on, dedicated sensors to automatically identify when a patient enters an MRI field and converts the device to MRI mode.

The device returns to its permanent programming after the scan is completed, preventing any pre- or post-scan programming needs.

Amvia Edge is its latest offering in cardiac rhythm management and is the smallest single-chamber MR conditional pacemaker available in the market, said the medical device company.

Biotronik chief medical officer David Hayes said: “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.

“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) algorithm, which offers multiple, automatic therapies in response to detected stable atrial arrhythmias.

The technology may reduce the burden of atrial tachycardia, which increases a patient’s risk of stroke and heart failure and help avoid atrial remodelling.

Amvia Edge also features new tools that automate key tasks, such as pre-discharge checks.

Its EarlyCheck feature enables an automatic transfer of device reports and IEGM to the Home Monitoring Service Centre two hours after implant, eliminating in-person device interrogation.

Biotronik president Ryan Walters said: “Amvia Edge represents BIOTRONIK’s continued commitment to healthcare professionals to help them serve their patients.

“The clinical treatment options and built-in efficiencies of Amvia are designed to solve everyday challenges for patients, physicians, and caregivers.”