SOURCE: Edwards Lifesciences

Edwards Lifesciences

March 02, 2010 09:00 ET

Edwards SAPIEN XT Transcatheter Valve and Delivery Systems Receive CE Mark

IRVINE, CA--(Marketwire - March 2, 2010) -  Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received CE Mark for its Edwards SAPIEN XT transcatheter aortic heart valve, as well as its NovaFlex transfemoral and Ascendra 2 transapical delivery systems.

The company is beginning a disciplined European launch of the new valve and the 18 French NovaFlex delivery system, and will expand the number of commercial sites utilizing the system throughout the year.

The Edwards SAPIEN XT transcatheter valve enables doctors to replace failing aortic valves without major surgery. The leaflet design of this new valve is modeled after Edwards' clinically proven aortic tissue valves and its cobalt chromium frame provides improved radial strength and, therefore, enhanced circularity. The Edwards SAPIEN XT valve with the NovaFlex transfemoral delivery system is designed to provide easy, precise, balloon-expandable delivery of the valve.

"The Edwards SAPIEN XT valve platform offers best-in-class valve performance with a low-profile delivery system," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "We are excited about the new platform and our continued leadership in this transformational technology."

As heart teams continue to gain clinical experience with the Edwards SAPIEN XT valve on the Ascendra 2 transapical delivery system, Edwards will begin introducing that system commercially in Europe during the second quarter. The Ascendra 2 system features a reduced profile and is designed for improving ease-of-use when delivering the valve through a small incision between the ribs.

The Edwards SAPIEN XT valve is the second commercially available transcatheter valve in the Edwards SAPIEN product portfolio. Edwards is the only company to commercialize both transfemoral and transapical transcatheter aortic valve systems, which have been available in Europe since 2007. In the United States, the Edwards SAPIEN valve is an investigational device being studied as part of the world's only randomized, pivotal clinical trial of a transcatheter aortic valve and not yet available commercially.

About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://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, 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, Ascendra 2, Edwards SAPIEN XT and NovaFlex are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Ascendra, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, Magna, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

Contact Information

  • Media Contact:
    Sarah Huoh
    949-250-5070

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