www.fdanews.com/articles/183249-fda-approves-biotroniks-tiny-quadripolar-cardiac-resynchronization-therapy-pacemaker
FDA Approves Biotronik’s Tiny Quadripolar Cardiac Resynchronization Therapy Pacemaker
August 25, 2017
Biotronik secured FDA approval for its Edora HF-T QP MR conditional quadripolar cardiac resynchronization therapy pacemaker (CRT-P).
The device allows physicians to tell the implant an MRI exam is coming up, so the device can to automatically engage its MRI safety mode during a scan.
The device has a total volume of only 15 cc, making it the smallest MR-conditional CRT-P on the U.S. market.