SOURCE: Edwards Lifesciences

Edwards Lifesciences

February 24, 2011 09:00 ET

Edwards Lifesciences Expands Treatable Patient Population With European Approval of Larger Transcatheter Valve

IRVINE, CA--(Marketwire - February 24, 2011) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, has received CE Mark for the 29 millimeter version of its Edwards SAPIEN XT transcatheter aortic heart valve. 

The valve will be available with the Ascendra transapical delivery system for implantation through a small incision between the ribs, and this new offering increases the valve portfolio to three sizes.

"We knew it was important to provide patients with a 29 millimeter valve, and we're pleased we can now help even more patients in need," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement.

The Edwards SAPIEN XT valve builds upon the innovative features of the Edwards SAPIEN valve, incorporating a tissue leaflet design that is modeled on Edwards' surgical aortic tissue valves -- which have clinically proven durability -- and a cobalt chromium frame that provides improved radial strength. The Edwards SAPIEN XT valve has been used widely by clinicians throughout Europe since its commercial launch in the region in 2010, and is an investigational device in the United States that is being studied in The PARTNER II Trial, a randomized controlled study. 

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 the availability and benefits of new transcatheter valve products and the timing and progress of clinical studies relating to these 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 those expressed or implied by the forward-looking statements based on a number of factors including but not limited to market developments, expanded clinical experience, or unexpected supply, regulatory or quality matters. 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, 2009.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, Ascendra, PARTNER and PARTNER II are trademarks of Edwards Lifesciences Corporation. 

Contact Information

  • Media Contact:
    Sarah Huoh or Janet Kim
    949-250-5070

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