Edwards Lifesciences Comments on TAVR National Coverage Decision

IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today issued the following statement in response to the national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR) released by the Centers for Medicare & Medicaid Services (CMS):

“Edwards is pleased that this updated policy represents an important step toward improving and expanding patient access to TAVR while reinforcing the value of a multidisciplinary Heart Team. Aortic stenosis is a serious, progressive disease, and delays in evaluation, diagnosis and treatment increase the risk of irreversible heart damage and hospitalization, leading to poorer outcomes and higher healthcare costs, as well as an increased risk of death. The modernized policy recognizes the importance of timely care by supporting a more streamlined patient care journey and giving Heart Teams greater flexibility to apply their expertise to both patient evaluation and treatment based on each patient’s clinical needs. Throughout this NCD process, our priority has remained the same: ensuring appropriate access to TAVR, a mature, reproducible procedure backed by an unparalleled body of evidence and support of the Heart Team approach. We appreciate the leadership of CMS and engagement of all stakeholders who contributed evidence, perspectives and expertise to inform this important review of Medicare coverage policy.”

Edwards is encouraged by the opportunities the updated policy creates for patients and TAVR programs. As implementation and adoption of the NCD are expected to take time, the company has confidence in its previously communicated financial guidance for 2026. Edwards will provide 2027 and longer-term guidance at its investor conference in December.

As always, Edwards remains committed to working with stakeholders to support thoughtful implementation of the NCD and timely access and high-quality TAVR care for patients in need.

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements regarding the impact and opportunities the updated policy will have on patients, including improving and expanding patient access to TAVR, statements regarding financial guidance for 2026, 2027 and longer term, our commitment to working with stakeholders to support the thoughtful implementation of the NCD and timely access for appropriate patients, and our commitment to providing high-quality TAVR care to patients in need, and other statements that are not historical facts. 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. Investors are cautioned not to unduly rely on such forward-looking statements.

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 as detailed in the company's filings with the Securities and Exchange Commission. 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 or its affiliates. All other trademarks are the property of their respective owners.