SOURCE: Edwards Lifesciences

Edwards Lifesciences

September 29, 2011 13:49 ET

Edwards Lifesciences Comments on CMS National Coverage Analysis of Transcatheter Heart Valves

IRVINE, CA--(Marketwire - Sep 29, 2011) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today issued the following statement regarding the initiation of a National Coverage Analysis of transcatheter aortic valve replacement by the Centers for Medicare & Medicaid Services (CMS):

Edwards was aware for some time that CMS was considering initiating an NCA. The company believes a well-written National Coverage Determination (NCD) that ensures adequate patient access to this important and rapidly evolving therapy would be a positive for patients and physicians. The NCD draft is just entering the public comment period, and we expect it to evolve as the societies, regulators and other stakeholders provide their input on the important details.

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 potential outcomes of a National Coverage Determination for transcatheter valve replacement. 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 decisions. 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 and the stylized E logo 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