Edwards lifesciences has received CE mark approval for European commercial sales of its Edwards Sapien transcatheter aortic heart valve technology with the RetroFlex transfemoral delivery system.
The company claims it is the first transcatheter bovine pericardial valve incorporating technological advancements and design elements that allow for greater ease of implantation by physicians. 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.
"In this pioneering procedure, the skill sets of the surgeon and the interventional cardiologist complement each other to provide for better patient care," said Martin B Leon, Professor of Medicine and Associate Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center and the principal investigator for the Edwards PARTNER pivotal trial in the US. "Several years of clinical experience have demonstrated that optimal outcomes can be achieved with a collaborative, multidisciplinary team."
The Sapien transcatheter heart valve integrates balloon-expandable stent technology that leverages Edwards' proprietary bovine pericardial tissue and 30 years of design and manufacturing expertise. With the RetroFlex transfemoral delivery system, the Sapien 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.
Edwards has achieved almost 500 implants of the transcatheter heart valve through a series of extensive clinical trials and feasibility studies in Europe, the US and Canada. The company is proceeding on schedule with European launch preparations, including establishing training centres, 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 the 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. The Ascendra transapical delivery system is expected to receive CE mark by the end of 2007.
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