The Konect Resilia aortic valved conduit (AVC) [Image courtesy of Edwards Lifesciences]
Edwards Lifesciences (NYSE:
EW) announced today that FDA has approved its Konect Resilia aortic valved conduit (AVC).
Edwards describes the Konect Resilia as the first ready-to-implant option for bio-Bentall procedures, a complex surgery that involves the replacement of a person's aortic valve, aortic root and the ascending aorta.
Surgeons find themselves having to perform nearly a third of Bentall procedures in an emergency setting.
"Until now, surgeons did not have a pre-assembled option that was FDA approved, so those utilizing bovine tissue valves for Bentall procedures needed to manually assemble a valve with a conduit in the operating room," said Dr. Joseph Bavaria, surgery professor and vice chief of the division of cardiovascular surgery at the University of Pennsylvania.