Edwards Lifesciences, a developer of heart valves and hemodynamic monitoring systems, has received CE Mark in Europe for its Edwards Intuity valve system for use in patients undergoing surgical aortic valve replacement (AVR).
The system, which consists of a bovine pericardial heart valve and delivery system, facilitates small incision surgery and valve deployment during AVR procedures. The company plans to begin a European launch at centers participating in post-approval clinical studies. Edwards Intuity leverages the design of Edwards' pericardial valve technology, featuring a balloon-expandable frame designed to facilitate annular placement.
The Edwards Intuity valve system is not yet available for sale or use in the U.S.