Edwards Comments On CMS Initiation Of National Coverage Analysis For TAVR

IRVINE, Calif., Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today commented on the announcement by the U.S. Centers for Medicare and Medicaid Services (CMS) about a National Coverage Analysis (NCA) for transcatheter aortic valve replacement (TAVR):

CMS announced that it has opened the NCA to reconsider the National Coverage Determination (NCD) released in 2012 for TAVR. This development was clearly expected and the analysis will examine the extensive body of evidence regarding the clinical, economic and quality of life benefits of TAVR.

As we move forward, our priority will be on assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time. We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important policy, which will define the future of heart valve patients' access to this life-saving care.

The tracking sheet and full request letter are 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, expected impacts of the National Coverage Determination on 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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  • Edwards Lifesciences

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