FDA approves aortic valve conduit for complex surgeries
Edwards Lifesciences announced that the FDA has approved an aortic valve conduit for use during bio-Bentall procedures.
The aortic valve conduit (Konect Resilia), which is used during surgery to replace a patient’s aortic root, aortic valve or ascending aorta, incorporates tissue with preservation technology to improve durability of the valve, according to a press release from the company. This tissue technology allows the aortic valve conduit to be stored in dry packaging conditions.
“Until now, surgeons did not have a preassembled 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,” Joseph E. Bavaria, MD, Brooke Roberts-William M. Measey Professor of Surgery and vice chief of the division of cardiovascular surgery at the University of Pennsylvania, said in the release. “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.”
Bentall procedures are often performed in patients with valve disease who experience issues with the aorta such as aneurysm, separation or tears in the aortic walls, regurgitation and Marfan syndrome, according to the release.
“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,” Daveen Chopra, corporate vice president of surgical structural heart for Edwards Lifesciences, said in the release.