SOURCE: Edwards Lifesciences

Edwards Lifesciences

May 20, 2011 03:10 ET

Edwards' European Registry of 2,300 Transcatheter Patients Demonstrates Successful One-Year Outcomes

PARIS--(Marketwire - May 20, 2011) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that clinicians continued to achieve successful one-year outcomes in high-risk or inoperable patients undergoing transcatheter aortic valve replacement during the first two years of commercialization of the Edwards SAPIEN valve. Data on the more than 2,300 patients enrolled in the post-market European SOURCE Registry since November 2007 were presented in a late-breaking clinical trial session today at EuroPCR 2011.

Despite high predicted mortality and multiple co-morbidities in many of these patients, survival at one year was 76 percent in the 1,038 patients treated as part of Cohort I (first year of commercialization), and 77 percent in the 1,269 patients treated as part of Cohort II (second year of commercialization). For all of the patients in both cohorts, the one-year survival for those receiving transfemoral valve replacement (via the femoral artery), was 80.1 percent, and for transapical patients (via a small incision between the ribs), it was 74.2 percent.

"By establishing the rigorous SOURCE post-market registry and continuing to follow the outcomes of patients into the second year of commercialization, we are better able to understand how this therapy is applied in a real-world setting, affirming our approach to its commercial introduction," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "Of note, EuroSCORE predicted 30-day operative mortality was similar for patients in the first and second years of commercialization, with a mean of 27.6 and 25, respectively."

The SOURCE Registry includes data from patients treated with the Edwards SAPIEN transcatheter heart valve at 32 European centers in its initial Cohort I, and 37 centers in Cohort II. One year follow-up data were obtained on 98 percent of patients. This is the largest reported experience in the world with data on consecutive patients within each hospital who were treated with transcatheter heart valves delivered transfemorally or transapically. In Cohort I, there were 463 transfemoral and 575 transapical procedures; in Cohort II, there were 457 transfemoral and 812 transapical procedures. The principal investigators of the SOURCE Registry are Olaf Wendler, M.D., Ph.D., clinical director for cardiology and cardiothoracic surgery, King's College Hospital, and Martyn Thomas, M.D., clinical director for cardiothoracics, Guy's and St. Thomas' NHS Foundation Trust.

Also today at EuroPCR, Edwards announced the receipt of CE Mark approval for sale in the European Union of the NovaFlex+ transfemoral delivery system for use with the next-generation Edwards SAPIEN XT transcatheter heart valve. This new system incorporates modifications focused on improving ease of use and is designed to make valve alignment prior to deployment more reliable. Edwards is launching this system, as well as the eSheath expandable sheath technology, at EuroPCR. The eSheath, which received CE Mark earlier this year, enables the use of a low profile sheath and is designed to reduce vascular complications. The Edwards SAPIEN valve, Edwards SAPIEN XT valve, NovaFlex+ and eSheath are investigational devices not yet available commercially in the United States.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements regarding potential clinical results and benefits of the Edwards SAPIEN and Edwards SAPIEN XT valves, the NovaFlex+ system and the eSheath. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected results following expanded clinical experience and market developments. These and other factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2010.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, eSheath and NovaFlex+ are trademarks of Edwards Lifesciences Corporation.

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