Edwards Lifesciences has announced approval from the US Food and Drug Administration (FDA) for the KONECT RESILIA aortic valved conduit (AVC), a ready-to-implant solution for bio-Bentall procedures, a surgery that involves replacement of a patient’s aortic valve, aortic root and the ascending aorta.
The KONECT device offers the advanced RESILIA tissue, which incorporates integrity-preservation technology that may help improve valve durability, Edwards Lifesciences said in a press release. The RESILIA tissue technology also allows devices to be stored under dry packaging conditions, facilitating ease of use during patient care.
“Until now, surgeons did not have a pre-assembled option that was FDA approved, so those utilising bovine tissue valves for Bentall procedures needed to manually assemble a valve with a conduit in the operating room,” said Joseph E Bavaria, vice chief of the division of cardiovascular surgery, University of Pennsylvania (Philadelphia, USA). “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,” said 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.”