Press releases

BALTIMORE, July 25, 2018 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today commented on the U.S. Centers for Medicare and Medicaid Services' (CMS) advisory panel regarding evidence pertaining to procedural volume requirements for transcatheter aortic valve replacement (TAVR) programs:

"Today's advisory panel meeting provided a review of current and possible future impacts of volume requirements on TAVR centers in the United States.  In the absence of definitive evidence linking high volumes of procedures to high quality outcomes for TAVR patients, we continue to believe the best course of action is to focus on defined quality measures for both new programs and also those continuing to offer this life-saving, less-invasive therapy.

"Our priority is assuring that all people with heart valve disease have equitable access to all treatment options.  The primary risk severe aortic stenosis patients face today does not come from complications during treatment – rather, it comes from not receiving treatment at all.  We believe access to both TAVR and surgical valve replacement procedures should be thoughtfully expanded, based on the needs of the patient community, but restricted to programs that deliver high quality outcomes."

CMS opened the national coverage analysis (NCA) of the national coverage determination (NCD) for TAVR in late June, and it is accepting initial public comments through July 27.  CMS expects to complete the NCA within the next 12 months.  More information about the TAVR NCA is available at: https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=293&type=Open&bc=ACAAAAAAQAAA&  

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 expected impacts of the panel meeting on the National Coverage Determination, product availability and patient access. 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 results 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 developments in regulatory or reimbursement matters, or unanticipated quality, manufacturing or regulatory issues.  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, 2017. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards and Edwards Lifesciences are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

 

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