Edwards SAPIEN 3 Valve Receives FDA Approval For Aortic, Mitral Valve-In-Valve Procedures

IRVINE, Calif., June 5, 2017 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received U.S. Food and Drug Administration (FDA) approval for aortic and mitral valve-in-valve procedures using the Edwards SAPIEN 3 transcatheter heart valve. The SAPIEN 3 valve is the first transcatheter heart valve approved in the U.S. for the treatment of both aortic and mitral patients who are at high risk for a subsequent open-heart surgery to replace their bioprosthetic valve.

Edwards Lifesciences logo. (PRNewsFoto/Edwards Lifesciences Corporation)

"Expansion of the SAPIEN 3 device indication to include valve-in-valve procedures is a meaningful advancement for patients at high risk of an additional open-heart valve procedure, particularly for those in need of a safe alternative for mitral valve replacement," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves.

This anticipated FDA approval of the indication expansion was supported by real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry. The TVT Registry includes information and outcomes on patients undergoing transcatheter valve replacement and repair procedures in the United States.

"This approval brings a safe and effective transcatheter therapy to patients who would do very poorly with repeat open-heart surgery," said John Carroll, M.D., professor of cardiology at the University of Colorado School of Medicine and director of interventional cardiology at the University of Colorado Hospital, Denver and member of the TVT Registry Steering Committee. "I am pleased to see that the FDA recognizes the value of the high-quality evidence generated by the STS-ACC TVT Registry and its ability to play an important role in assessing 'real-world' clinical results in specialty indications, such as valve-in-valve, and for particular patient groups, such as those needing replacement of a bioprosthetic mitral valve."

The Edwards SAPIEN 3 valve was approved by the FDA in 2015 for severe, symptomatic aortic stenosis patients at high risk for open-heart surgery, and, in 2016, received approval for the treatment of patients who are at intermediate risk for open-heart surgery. The SAPIEN 3 valve builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves.

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 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 made by Mr. Wood and Dr. Carroll.  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, unanticipated outcomes of longer term clinical experience with the product, 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, 2016. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, SAPIEN, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

 

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Contact Information :
Media, Heather Bukant, 949-250-5070, or
Investors, David K. Erickson, 949-250-6826, both of Edwards Lifesciences Corporation

Important safety information

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Important safety information

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

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