Early And Sustained Quality Of Life Improvements Seen For Intermediate Risk Patients Treated With Edwards Transcatheter Valves

WASHINGTON, Nov. 1, 2016 /PRNewswire/ -- Edwards Lifesciences Corporation EW, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced new data demonstrating dramatic and sustained improvements in quality of life for severe aortic stenosis (AS) patients at intermediate surgical risk treated with Edwards transcatheter heart valves. Study results were presented at the 28^th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Washington, D.C.

The new data, involving more than 3,000 patients enrolled in The PARTNER II Trial, showed dramatic improvements in cardiovascular health status as well as overall physical and mental well-being after transcatheter aortic valve replacement, or TAVR, with the Edwards SAPIEN XT and SAPIEN 3 valves. The health benefits with TAVR were early and sustained.

"Because AS patients are generally elderly and often have multiple comorbid conditions, many of them care more about maintaining or improving their quality of life rather than simply achieving a longer life," said David J. Cohen, M.D., Professor of Medicine at the University of Missouri-Kansas City and Director of Cardiovascular Research at Saint Luke's Mid America Heart Institute, who presented the late-breaking data from the PARTNER II randomized trial at TCT. "Taken together with previous data demonstrating very low mortality and disabling stroke rates with transfemoral TAVR among patients at intermediate surgical risk, these findings demonstrate that, for such patients, ­­­TAVR provides both early and late benefits that are important from the patient's perspective." 

In the quality-of-life study performed alongside the PARTNER II Trial comparing TAVR with surgical aortic valve replacement, patients treated via transfemoral TAVR with the SAPIEN XT valve saw substantially greater health status improvements at one month than patients treated with surgery. Overall, 71.1 percent of patients treated with transfemoral TAVR experienced health status improvements at one month compared with just 44.7 percent of patients treated surgically. Moreover, when mortality and the extent of quality of life improvement were evaluated together, transfemoral TAVR with the SAPIEN XT valve was superior to surgery at the 1- and 2-year follow-up, as well. In the transthoracic cohorts, mortality and quality of life benefits were similar to surgery.

Building off the foundational work of the PARTNER II randomized trial, a separate analysis of intermediate-risk patients treated with the SAPIEN 3 valve in the PARTNER II Trial demonstrated even greater health status improvements than the SAPIEN XT valve at one month with persistent benefits compared with surgery at one year. These data were presented by Suzanne J. Baron, M.D., M.Sc., Assistant Professor of Medicine at the University of Missouri-Kansas City and a Clinical Scholar at Saint Luke's Mid America Heart Institute.

The SAPIEN XT and SAPIEN 3 valves are the only transcatheter aortic valves approved for the treatment of intermediate-risk patients in the United States.

Cohen 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, statements by Dr. Cohen and statements regarding expected product benefits and procedural outcomes. 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 the roll-out and benefits of the technology 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 outcomes after more expanded clinical experience, or unexpected changes or delays related to product manufacturing or clinical practice. 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, 2015. Our filings, along with important product safety information, are available at www.Edwards.com.

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

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