A Medical Device Daily
Edwards Lifesciences (Irvine, California) this week reported receiving CE mark approval for its Sapien transcatheter aortic heart valve technology with the RetroFlex transfemoral delivery system.
The valve is implanted via a minimally-invasive procedure, without requiring open-heart surgery and so is designed to treat patients with severe aortic heart valve stenosis (a narrowing of the valve that restricts blood flow), who are considered high-risk or non-operable for conventional open-heart valve replacement surgery.
The heart valve integrates balloon-expandable stent technology using Edwards’ proprietary bovine pericardial tissue. With the RetroFlex transfemoral delivery system, the valve is compressed onto the balloon to the approximate diameter of a pencil and threaded through the patient’s circulatory system from the leg and expanded securely into place directly over the diseased aortic valve.
“This is a landmark achievement for this transformational technology, which holds promise for the large number of high-risk patients suffering from severe aortic stenosis,” said Michael Mussallem, CEO and chairman of Edwards. “As the global leader in heart valve therapy, we are committed to working closely with our European clinical partners on this transcatheter technology, in order to provide optimal clinical outcomes for the many high-risk patients in need of aortic valve replacements, who might otherwise have limited or no treatment options.”
Edwards Lifesciences specializes in development of tissue heart valves.