Edwards Lifesciences Corporation (EW.NYSE) received U.S. Food and Drug Administration (FDA) approval for the KONECT RESILIA aortic valved conduit (AVC) today.
The AVC is the first solution for bio-Bentall procedures, which are complex surgeries involving replacing a patient’s aortic valve, aortic root and ascending aorta. The KONECT device offers advanced RESILIA tissue, using technology designed to assist improving valve durability.
“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. The KONECT device represents a meaningful advancement that offers surgeons a preassembled device with two leading technologies, which can streamline treatment for patients requiring this complex and technical procedure,” said Joseph E. Bavaria, MD, Brooke Roberts-William M. Measey professor of surgery and vice chief of the division of cardiovascular surgery, University of Pennsylvania.
Close to 30% of Bentall procedures are performed in an emergency setting, generally after patients with valve disease experience a number of issues with the aorta, including a number of issues. The first being aneurysm, which is a bulging in the aorta that can be deadly if it ruptures. The second being regurgitation, which is leakage of blood backwards into the heart because the valves don’t close properly. The third most common reason is either separation or a tear in the aorta walls, and Marfan’s syndrome, in which a birth defect in the connective tissue weakens the aortic wall.
“The KONECT device combines Edwards’ expertise innovating bovine pericardial tissue technologies, such as RESILIA, with the proven clinical history of the Gelweave Valsalva graft. Because the typical patient is under the age of 60, advanced technologies such as the KONECT device with the RESILIA tissue might provide extended valve durability for a more active patient population” said Daveen Chopra, Edwards’ corporate vice president, surgical structural heart.