Press releases

IRVINE, Calif., June 21, 2019 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today commented on the final updated U.S. Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) pertaining to transcatheter aortic valve replacement (TAVR) programs:

"We commend CMS on its thoughtful approach toward updating the TAVR policy. Throughout the NCD process, Edwards emphasized that the priority must be ensuring timely patient access to high-quality care, so that clinicians can provide all people with heart valve disease with the therapy that is right for them. Often, the primary risk facing severe aortic stenosis patients is not treatment complications, but the risk of not receiving treatment at all. 

"Many of the core elements of the updated NCD better reflect today's practices in the treatment of patients with severe AS, the needs of those patients and the robust evidence and technology enhancements that have occurred in the last several years. We believe the modernized requirements and more streamlined patient evaluation process are meaningful enhancements that may help ensure equitable access for more patients suffering from severe AS. We are encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR in the U.S., which Edwards believes could reasonably coincide in the future with discontinuation of Coverage with Evidence Development. We look forward to continuing to engage with all of the stakeholders around the best way to ensure high quality and appropriate access for all Medicare beneficiaries in need of treatment for structural heart disease."

More information about the final TAVR NCD is available at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=293&bc=AAAAAAAAACAA&. The company is not updating or changing its financial guidance.

About Edwards Lifesciences

Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.Edwards.com and follow us on Twitter @EdwardsLifesci.

This news release includes forward-looking statements within the meaning of Section 27A of the 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 financial guidance and expected future impacts of 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, 2018. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences and the stylized E logo are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.  This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries.

 

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