Edwards’ KONECT RESILIA Aortic Valved Conduit Wins FDA Approval For Bio-Bentalls

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Edwards Lifesciences won FDA approval for its KONECT RESILIA aortic valved conduit, a device designed specifically for performing bio-Bentall procedures. Typically, these complex surgeries require physicians to remove the aortic root, the aortic valve, and at least a part of the ascending aorta, and replace them with an artificial valve and an aortic graft that are sewn together. The KONECT RESILIA is essentially a prosthetic valve and an aortic graft in a single device, making it easier and faster to complete bio-Bentall procedures.

The valve leaflets are made from Edwards’ RESILIA, a material made from bovine pericardium that was transformed to allow it to work for years inside the human body. One important advantage of RESILIA is that devices made using it can be stored within dry packaging and used as necessary.

“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 Joseph E. Bavaria, MD, Brooke Roberts-William M. Measey professor of surgery and vice chief of the division of cardiovascular surgery, University of Pennsylvania, in an Edwards press 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.”

“The KONECT device combines Edwards’ expertise innovating bovine pericardial tissue technologies, such as RESILIA, with the proven clinical history of the Gelweave Valsalva graft,” added Daveen Chopra, Edwards’ corporate vice president, surgical structural heart. “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.”

Here’s a video from Edwards presenting the KONECT RESILIA:

Via: Edwards Lifesciences…





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