Edwards Lifesciences, a provider of heart valves and hemodynamic monitoring sysyems, has obtained CE mark for its Edwards Intuity Valve system for use in patients undergoing surgical aortic valve replacement (AVR).
The system, which comprises a bovine pericardial heart valve and novel delivery system, facilitates small incision surgery and rapid valve deployment during AVR procedures.
The valve utilizes the design of the company’s pericardial valve technology and features a balloon-expandable frame which is designed to facilitate rapid and secure annular placement to reduce overall procedural time.
Edwards Intuity Valve system TRITON study investigator and Leipzig Heart Center Cardiac Surgery associate director Michael Borger said this system includes features designed to facilitate a faster and more efficient procedure, so physicians have the opportunity to provide patients a desired therapeutic option without added procedural complexity.