SOURCE: Edwards Lifesciences Corporation

September 15, 2008 07:00 ET

Edwards Lifesciences Presents New Transcatheter Heart Valve Data at EACTS

IRVINE, CA and LISBON, PORTUGAL--(Marketwire - September 15, 2008) - Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced today that new data on the Edwards SAPIEN transcatheter heart valve with the Ascendra transapical delivery system were presented at the 22nd annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Lisbon, Portugal.

"Presentations of the latest data on the transapical approach for the Edwards SAPIEN valve highlight the continued progress of this procedure, which was pioneered three years ago and introduced commercially in Europe earlier this year," said Michael A. Mussallem, Edwards' chairman and CEO. "These patients were not good candidates for open heart surgery due to their extensive co-morbidities. The leadership and commitment to improved patient selection and procedure management by surgeons have driven improved outcomes as demonstrated in the SOURCE registry and the substantial experience in Leipzig, Germany. Edwards Lifesciences is committed to the advancement of this procedure, which we believe is becoming an important option for high risk aortic stenosis patients."

Interim follow-up results from the pre-commercial transapical PARTNER EU registry of 67 transapical patients were presented on Saturday and showed a 30-day survival of 82 percent and a six-month survival of 56 percent. PARTNER EU is a European registry conducted primarily in 2007 that represents Edwards' early transapical experience.

The 30-day results from the post-approval commercial SOURCE registry were presented today. SOURCE is designed to evaluate commercial use of the Edwards SAPIEN valve with a prescribed training and proctoring program. It is a registry of procedural and short-term clinical outcomes. The current data reflect 309 cases at hospitals in 12 European countries. Survival at 30 days was 88 percent.

The largest single site transapical experience from Leipzig was also updated, and showed continued progress in early and late mortality on a cohort of 113 patients. Six-month survival was 74 percent and 12-month survival was 71 percent.

In addition to the data presentations, a live case transmitted from Universität Leipzig on Saturday demonstrated the transcatheter valve replacement procedure with the Ascendra transapical delivery system. The patient received a thoracic epidural and was not intubated, which allowed the patient to be awake throughout the procedure. The Edwards SAPIEN transcatheter valve was successfully deployed.

Six-month transfemoral data from PARTNER EU and 30-day transfemoral data from SOURCE will be presented at TCT 2008 in October.

The Edwards SAPIEN transcatheter heart valve is approved for commercial sale in Europe. In the United States, it is an investigational device that is not available for sale. The Edwards SAPIEN valve is being studied in the U.S. PARTNER trial, which is a randomized trial that only recently began enrolling transapical patients.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. In 2008, Edwards celebrates 50 years of partnering with clinicians to develop life-saving innovations. The company's global brands, which are sold in approximately 100 countries, include CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://www.edwards.com.

Edwards and Edwards SAPIEN are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Ascendra, CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna, Swan-Ganz and ThermaFix are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

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