FDA Clears Edwards' KONECT RESILIA Aortic-Valved Conduit

Patrice Wendling

July 15, 2020

The US Food and Drug Administration (FDA) has approved an aortic-valved conduit (KONECT RESILIA, Edwards Lifesciences) for bio-Bentall procedures, the company announced today.

"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," Joseph E. Bavaria, MD, a consultant to Edwards and vice chief of cardiovascular surgery, University of Pennsylvania, Philadelphia, said in a company news 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," he said.

The bio-Bentall procedure involves replacement of the aortic valve, aortic root, and ascending aortic and is used to treat combined disease of the aorta, including aneurysm, regurgitation, separation or tears in the aortic wall, and Marfan syndrome.

The typical patient is younger than 60 years, and up to 30% of Bentall procedures are performed in an emergency setting, according to the release.

The KONECT device combines Edwards' RESILIA bovine pericardial tissue and the Gelweave Valsalva graft. The RESILIA tissue incorporates "integrity-preservation technology" that may help improve valve durability, the company said. The technology also allows devices to be stored under dry packaging conditions, facilitating ease of use.

Bavaria is a consultant to Edwards Lifesciences.

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