FT. LAUDERDALE, FL--(Marketwire - Jan 30, 2012) - Edwards Lifesciences Corporation (NYSE: [ EW ]), the global leader in the science of heart valves and hemodynamic monitoring, announced today that new data were presented on high-risk surgical patients with severe aortic stenosis treated with transapical transcatheter aortic valve replacement (TAVR) during the continued access period of Cohort A of The PARTNER Trial. The data on the Edwards SAPIEN transcatheter heart valve were presented by Todd M. Dewey, M.D., surgical director of structural heart disease and cardiac transplantation at Medical City Dallas Hospital, during the late-breaking clinical trial abstracts at The Society of Thoracic Surgeons' (STS) annual meeting in Ft. Lauderdale, Fla.

"It is encouraging that, in this much larger group of patients treated with transapical valve replacement, investigators observed a trend toward patients feeling better faster and having improved outcomes. We believe this more recent experience adds strong new support to the transapical procedure as an important option for patients who are at high-risk for surgery," said Michael A. Mussallem, Edwards' chairman and CEO.

After the randomized enrollment of 104 transapical patients in The PARTNER Trial, another 822 patients were treated transapically during the non-randomized continued access (NRCA) program that enrolled between Sept. 2009 and Sept. 2011. The average predicted risk of operative mortality at 30 days, according to the STS Adult Cardiac Database, was 12.2 percent. During continued access, mortality at 30 days was 8.2 percent and, at one year, it was 23.6 percent. (See tables below for additional details.)

The randomized portion of The PARTNER Trial had previously demonstrated that, for the patients treated with transapical TAVR, mortality at 30 days and one year was 8.7 percent and 29.1 percent, respectively. The STS score of average predicted risk of operative mortality at 30 days in this group of patients was 12.1 percent. Patients not randomized to TAVR received valve replacement via traditional open-heart surgery.

After the procedure, early symptom improvement was observed as measured by the New York Heart Association (NYHA) class, measured I through IV. At baseline, 5 percent of continued access patients were assessed as NYHA class I or II, and at 30 days, this number increased to 77 percent. At one year, the benefits of aortic valve replacement were evident in all groups, as measured by improvements in NYHA class.

All percents are Kaplan-Meier estimates. Comparisons of NRCA and randomized cohorts are limited, as the continued access group was not randomized.

In summary, for NYHA, class I is defined as asymptomatic heart disease; class II is comfortable at rest, with symptoms during normal activity; class III is comfortable at rest, with symptoms during a less than normal level of activity; class IV is symptomatic at rest. The percentages noted in the table above are calculated for survivors evaluated at 30 days and one year post-procedure, through Sept. 2011.

In Nov. 2011, the Edwards SAPIEN transcatheter heart valve received FDA approval for the treatment of certain inoperable patients; it is currently an investigational device for the treatment of high-risk patients in the U.S. In Cohort A of the PARTNER Trial, high-risk surgical patients were randomized to determine whether a less-invasive transcatheter approach could provide equivalent clinical results to traditional open-heart surgery. The data from Cohort A demonstrated that the study achieved its primary endpoint at one year.

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, Mr. Mussallem's comments and statements regarding the importance of the transapical procedure as a treatment option. 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 expanded clinical experience and the uncertain outcome of the U.S. regulatory approval process. These 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 and PARTNER are trademarks of Edwards Lifesciences Corporation.