Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives CE Mark
IRVINE, Calif., Nov. 16, 2018 -- 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 CE Mark for the SAPIEN 3 Ultra system for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients.
"The SAPIEN 3 Ultra system incorporates enhancements to the valve, as well as a new delivery system, which are designed to further build on the exceptional outcomes of the SAPIEN 3 valve, which has shown extremely low rates of mortality and disabling stroke," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "With the SAPIEN 3 Ultra system, we are building on our best-in-class performance to further advance and improve patient care."
The Edwards SAPIEN 3 Ultra system (valve sizes 20, 23 and 26mm) features enhancements to the valve, and a new delivery system and sheath. The valve features a heightened outer skirt designed to eliminate paravalvular leak. The SAPIEN 3 Ultra delivery system, which consists of a new low-profile 14-French Axela expandable sheath, introduces an "on balloon" design, removing the need for valve alignment during the procedure.
"The Edwards SAPIEN 3 Ultra system incorporates features designed to help simplify and improve the efficiency of the procedure," said John Webb, M.D., director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital, Vancouver, and professor of cardiology at the University of British Columbia. "This design innovation represents a meaningful advancement over previous generations of this technology."
The SAPIEN 3 Ultra system builds on Edwards' decades of engineering and experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves.
As previously announced, Edwards will introduce the SAPIEN 3 Ultra system in Europe as part of a controlled rollout, which includes training, to ensure high procedural success of this advanced valve and delivery system.
The SAPIEN 3 Ultra system will not be launched at this time in Germany, as a result of the preliminary injunction that Boston Scientific chose to implement in the country. Edwards is disappointed in Boston Scientific's tactic to limit access of this new therapy. The German court will hold a full hearing on the merits of the dispute in mid-2019, and Edwards continues to believe that it will ultimately prevail in this matter. The SAPIEN 3 and CENTERA valve systems remain available in Europe. The German case pertains to a European patent that Boston acquired in 2017 (No. EP 2 949 292).
The SAPIEN 3 Ultra system is not approved in the United States; Edwards previously discussed that it anticipates it will receive U.S. Food and Drug Administration approval for the SAPIEN 3 Ultra system around the end of 2018.
Dr. Webb is a consultant to Edwards Lifesciences.
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, Mr. Wood's and Dr. Webb's statements and statements regarding expected timing, scope and outcomes of the product launch. 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 delays or changes in the product introduction, unanticipated outcomes of clinical experience with the product, or unanticipated manufacturing, legal, quality or regulatory delays or 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, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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