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The Edwards SAPIEN transcatheter heart valve is implanted via aminimally-invasive procedure, without requiring open-heart surgery. It is thefirst transcatheter bovine pericardial valve incorporating technologicaladvancements and design elements that allow for greater ease of implantationby physicians. The valve is designed to treat patients with severe aorticheart valve stenosis (a narrowing of the valve that restricts blood flow), whoare considered to be high-risk or non-operable for conventional open-heartvalve replacement surgery.
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"This is a landmark achievement for this transformational technology,which holds promise for the large number of high-risk patients suffering fromsevere aortic stenosis," said Michael A. Mussallem, Edwards Lifesciences'chairman and CEO. "As the global leader in heart valve therapy, we arecommitted to working closely with our European clinical partners on thistranscatheter technology, in order to provide optimal clinical outcomes forthe many high-risk patients in need of aortic valve replacements, who mightotherwise have limited or no treatment options."
"In this pioneering procedure, the skill sets of the surgeon and theinterventional cardiologist complement each other to provide for betterpatient care," said Martin B. Leon, MD, Professor of Medicine and AssociateDirector of the Center for Interventional Vascular Therapy at ColumbiaUniversity Medical Center and the principal investigator for the EdwardsPARTNER pivotal trial in the United States. "Several years of clinicalexperience have demonstrated that optimal outcomes can be achieved with acollaborative, multi-disciplinary team."
The Edwards SAPIEN transcatheter heart valve integrates balloon-expandablestent technology that leverages Edwards' proprietary bovine pericardial tissueand 30 years of design and manufacturing expertise. With the RetroFlextransfemoral delivery system, the Edwards SAPIEN valve is compressed onto theballoon to the approximate diameter of a pencil and threaded through thepatient's circulatory system from the leg and expanded securely into placedirectly over the diseased aortic valve.
Edwards has achieved almost 500 implants of the transcatheter heart valvethrough a series of extensive clinical trials and feasibility studies inEurope, the U.S. and Canada. The company is proceeding on schedule withEuropean launch preparations, including establishing training centers,selecting proctors for commercial site training, and progressingcountry-specific reimbursement plans, and will begin selling the device, asplanned, in the fourth quarter of 2007.
The company has also submitted for CE Mark approval the Edwards SAPIENtranscatheter heart valve with the Ascendra transapical delivery system -- inwhich the valve is inserted between the ribs -- providing interventionalcardiologists and surgeons with a second valve delivery option. The Ascendratransapical delivery system is expected to receive CE Mark by the end of theyear.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular diseasetreatments, is the number-one heart valve company in the world and the globalleader in acute hemodynamic monitoring. Headquartered in Irvine, Calif.,Edwards focuses on specific cardiovascular disease states including heartvalve disease, peripheral vascular disease and critical care technologies. Thecompany's global brands, which are sold in approximately 100 countries,include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent,PERIMOUNT Magna and Swan-Ganz. Additional com
