Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter H... (y at ColumbiaUniversity Medical Center a...)

Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve

Date:9/5/2007

y at Columbia University Medical Center and the principal investigator for the Edwards PARTNER pivotal trial in the United States. "Several years of clinical experience have demonstrated that optimal outcomes can be achieved with a collaborative, multi-disciplinary team."

The Edwards 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 Edwards 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 U.S. and Canada. The company 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 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 the year.

About Edwards Lifesciences

Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular disease states including heart valve disease, peripheral vascular
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