SOURCE: Edwards Lifesciences

Edwards Lifesciences

November 10, 2011 14:33 ET

Quality of Life and Economic Analyses of Edwards SAPIEN Valve in High-Risk Patients Featured at TCT

SAN FRANCISCO, CA--(Marketwire - Nov 10, 2011) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that data were presented on the quality of life impact and cost effectiveness of transcatheter aortic valve replacement (TAVR) in patients at high risk for traditional open-heart surgery. These data were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The data were based on the clinical outcomes of Cohort A of The PARTNER Trial, a non-inferiority study in which patients with severe aortic stenosis were randomized to receive either TAVR with the Edwards SAPIEN valve (using a transfemoral or transapical approach) or open-heart surgery. Clinical data published earlier this year in The New England Journal of Medicine demonstrated that the study achieved its primary endpoint at one year, concluding that survival of patients treated with the Edwards SAPIEN valve was equivalent to those treated with surgical aortic valve replacement.

The quality of life (QOL) and economic analyses were performed as both a combined and access-site specific analysis for each of the two transcatheter valve delivery approaches. There were 699 patients enrolled in Cohort A: 244 patients received transfemoral TAVR and 104 received transapical TAVR. All remaining patients received surgical valve replacement.

"The benefits of transfemoral delivery of SAPIEN in these high-risk patients are very compelling. Even with first-generation technology, transfemoral SAPIEN improved the quality of life for patients in a meaningful way and was cost-effective. These results are better than we expected at this early stage," said Michael A. Mussallem, Edwards' chairman and CEO. "The transapical quality of life and cost-effectiveness results were not superior to surgery. This transapical experience was even earlier in its learning curve in The PARTNER Trial, and these data reflect a limited number of patients at each site. Surgeons in Europe, where the procedure has a robust adoption rate, have taught us that transapical SAPIEN clinical results have continued to improve and provide an important alternative to surgery for high-risk patients."

Quality of Life
Patients were assessed with a variety of validated methods in The PARTNER Trial upon enrollment and at one-, six- and 12-month intervals, on a broad range of factors, such as their symptoms and physical and social limitations.

In comparing transfemoral TAVR with surgery, the transfemoral patients felt better at one month, and had comparable results at one year to surgical aortic valve replacement, which is the current gold standard. With transapical TAVR, patients did not demonstrate a quality of life benefit at one month; however, the transapical and surgical groups showed comparable results at one year.

Economics
An economic analysis of Cohort A of The PARTNER Trial was performed to determine the relative value of TAVR versus surgery in high-risk patients. The transfemoral TAVR procedure was 87 minutes faster and the length of the hospital stay was more than six days shorter than surgery. The index admission costs were also $2,500 lower in TAVR patients. In comparing transapical TAVR with surgery, the transapical procedure was 130 minutes shorter and the length of hospital stay was one-and-a-half days less than surgery. However, index admission costs were $11,000 higher in transapical TAVR patients.

"We continue to be very pleased that TAVR with SAPIEN provides an important alternative for high-risk patients with severe aortic stenosis," said Mussallem. "We already see very favorable transfemoral outcomes. With continued experience and next-generation device enhancements, we believe that the quality of life and cost-effectiveness results for TAVR will continue to improve."

The Edwards SAPIEN valve received FDA approval for the treatment of inoperable patients; it is currently an investigational device for the treatment of high-risk patients in the U.S.

[Editor's note: The results highlighted in this release are the median of all data values. A copy of the slides from today's TCT presentations on The PARTNER Trial data (Cohort A quality of life and economics) are available on TCTMD.com.]

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 made by Mr. Mussallem and statements regarding studies for, and the benefits of, the Edwards SAPIEN valve. 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 the outcomes 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 regulatory developments or reimbursement decisions and the impact of longer-term clinical experience on expected product risks and benefits. 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 and is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Edwards SAPIEN and The PARTNER Trial are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

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