Edwards Lifesciences is set to begin clinical trial to assess its Intuity valve system, following an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA).
The prospective, multi-center study, which will enroll 500-700 patients, is designed to study the safety and effectiveness of the Intuity valve system in a single arm study that will follow standard heart valve guidance and use historical controls.
The Intuity valve system, comprising a bovine pericardial heart valve and balloon-expandable frame, is designed to facilitate small incision surgery and valve deployment with the goal of enabling faster surgical aortic valve replacement (AVR) procedures.
Edwards Lifesciences heart valve therapy corporate vice president Donald Bobo said, "The Intuity valve system is based on the design of our proven market-leading surgical valves, and includes a novel delivery system designed to enhance control, accuracy and simplicity throughout the implantation."
Swedish Heart and Vascular Institute cardiac surgical services executive director and chief Glenn Barnhart said, "This new valve platform is designed to provide a number of patient benefits, and we look forward to learning how a smaller incision and more rapid valve implantation may result in reduced operative time and improved patient outcomes."
