Edwards Lifesciences (Irvine, California) in early September, the world leader in the science of tissue valves, reported receiving CE mark approval for its SAPIEN transcatheter aortic heart valve technology with the RetroFlex transfemoral delivery system.
The Edwards SAPIEN transcatheter heart valve is implanted via a minimally-invasive procedure, the company calling it the first transcatheter bovine pericardial valve incorporating technological advancements and design elements that allow for greater ease of implantation. The valve is designed to treat patients with severe aortic heart valve stenosis, who are considered to be high-risk or non-operable for conventional open-heart valve replacement surgery.
"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.
The Edwards SAPIEN valve integrates balloon-expandable stent technology incorporating the comany's bovine pericardial tissue. Using the RetroFlex transfemoral delivery system, the SAPIEN 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.
Edwards reported about 500 implants of the transcatheter heart valve through a series of clinical trials and feasibility studies in Europe, the U.S. and Canada. It said it is proceeding on schedule with European launch preparations, including establishing training centers, selecting proctors for commercial site training, and progressing country-specific reimbursement plans, and will begin selling the device, as planned, in the fourth quarter of 2007.
The company has also submitted for CE mark approval for Edwards SAPIEN transcatheter heart valve with the Ascendra transapical delivery system — in which the valve is inserted between the ribs —providing interventional cardiologists and surgeons with a second valve delivery option. It said that it expects CE marking for the Ascendra transapical delivery system by the end of the year.
Martin Leon, MD, professor of medicine and associate director of the Center for Interventional Vascular Therapy at Columbia University Medical Center (New York), principal investigator for the PARTNER pivotal trial in the U.S., said, " Several years of clinical experience have demonstrated that optimal outcomes can be achieved with a collaborative, multi-disciplinary team."