SOURCE: Edwards Lifesciences

Edwards Lifesciences

November 15, 2010 16:45 ET

Edwards SAPIEN Transcatheter Heart Valve Demonstrates Substantial Improvement in Quality of Life in Inoperable Patients

CHICAGO, IL--(Marketwire - November 15, 2010) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that in addition to the improved survival seen in inoperable aortic stenosis patients treated with the Edwards SAPIEN transcatheter heart valve in The PARTNER Trial, a newly released analysis of the same patients shows that they also experienced substantially better quality of life. These results were presented today at the American Heart Association's Scientific Sessions 2010.

"The degree and immediacy of the quality of life improvement was striking, with significant benefits seen as early as one month. By one year, patients experienced both cardiovascular and physical health benefits, with the physical improvements roughly comparable to a 10-year reduction in age," said David J. Cohen, M.D., M.Sc., Director of Cardiovascular Research at St. Luke's Mid America Heart and Vascular Institute, and principal investigator for the quality of life sub-study that was funded by Edwards. "Quality of life is critically important, particularly for patients like those in this trial -- and they are not just surviving, but also thriving."

The 358 patients were assessed upon enrollment in The PARTNER Trial, and at follow-up intervals of one month, six months and 12 months, on a broad range of factors, such as their symptoms, physical and social limitations, and heart-failure related quality of life. Several scientifically validated surveys were used to collect information from the patient's own perspective, including the Kansas City Cardiomyopathy Questionnaire (KCCQ), the SF-12 Health Status Survey and the EQ-5D (EuroQOL).

On a scale from 0 to 100, where a 20-point improvement is considered substantial, the Edwards transcatheter valve patients had a 25-point improvement in quality of life scores compared to the control group at one year, using the KCCQ instrument. Similarly positive results were demonstrated for the other two surveys.

The PARTNER Trial is the first randomized, controlled pivotal trial of a transcatheter aortic heart valve. The Edwards SAPIEN transcatheter valve is an investigational device in the United States and not yet available commercially in this country. 

[Editor's note: An online press kit with information and graphics related to The PARTNER Trial is available -- to obtain a username and password, contact Edwards at (949) 250-5070.]

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 can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "expect," "intend," or other similar expressions and include, but are not limited to, the timing and progress of clinical studies relating to the company's transcatheter valve technologies and the market opportunity for transcatheter technologies. 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 that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements 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, 2009.

Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo and Edwards SAPIEN are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

Contact Information

  • Media Contacts:
    Sarah Huoh
    Janet Kim
    949-250-5070

    Investor Contact:
    David K. Erickson
    949-250-6826