BIOTRONIK Pacemakers Greenlit by FDA

Image credit: BIOTRONIK

German-based BIOTRONIK has received a nod from the United States’ Food and Drug Administration (FDA) for its suite of Amvia Edge pacemakers and cardiac resynchronisation therapy pacemakers (CRT-P).

Amvia Edge is claimed to be the smallest single-chamber, “MR-conditional” (that is, allowing patients to undergo MRI exams) pacemaker in the market.

Equipped with BIOTRONIK’s MRI Guard 24/7 Technology, the device can automatically detect when a patient enters an MRI field and transitions into a specific MRI mode. After the scan is complete, the device will independently revert to its original programming.

“MRI Guard 24/7 is a solution for real-world challenges, as we strive to improve safety and increase efficiencies for… patients [with cardiac implantable electronic devices] who need MRI access,” said BIOTRONIK Chief Medical Officer, Dr David Hayes in a press statement.

“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.”

See the full press statement from BIOTRONIK for further details.