Edwards Lifesciences has received the European CE Mark for its EDWARDS INTUITY aortic valve replacement system.
The bovine pericardial heart valve and complementary delivery system were designed to allow for quick deployment to be performed through a small incision, hopefully improving outcomes and leading to shorter recovery times.
More from the announcement:
The company plans to begin a disciplined European launch at centers participating in post-approval clinical studies.
“Minimally invasive therapies are increasingly being sought by patients because of their demonstrated benefits, and the EDWARDS INTUITY Valve System allows us to provide small incision aortic valve replacement with a proven valve platform,” said Prof. Michael Borger, M.D., Ph.D., associate director of the Department of Cardiac Surgery at the Leipzig Heart Center in Germany and investigator in the TRITON study, which evaluated the feasibility, safety and performance of the EDWARDS INTUITY Valve System. “This system includes unique 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.”
The EDWARDS INTUITY Valve System leverages the design of Edwards’ pericardial valve technology, which is based on the company’s nearly 30-year leadership in tissue valve design. The valve features an innovative balloon-expandable frame designed to facilitate rapid and secure annular placement intended to reduce overall procedural time. The novel delivery system is designed to enable control, accuracy and simplicity throughout implantation.
Press release: EDWARDS INTUITY Valve System Receives CE Mark