Significant Patient Benefits With Edwards Sapien Valve Demonstrated In 5-Year Partner Trial Data

Transcatheter Valve Durability Sustained Through Five Years

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Sep 13, 2014, 11:00 ET

WASHINGTON, Sept. 13, 2014 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced the presentation of five-year clinical outcomes for inoperable patients treated in The PARTNER Trial, the world's only prospective randomized trial for transcatheter aortic valve replacement (TAVR) in patients deemed too sick for open-heart surgery. The data were presented as part of the late-breaking clinical trials session at the 26^th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

Edwards Lifesciences logo. (PRNewsFoto/Edwards Lifesciences Corporation) (PRNewsFoto/Edwards Lifesciences Corporation)

"These longer term results from PARTNER's inoperable cohort indicated that TAVR was associated with a continued significant mortality benefit, persistent symptom benefit and a statistically significant reduction in rehospitalizations," said Michael J. Mack, M.D., chair, cardiovascular service line, Baylor Scott & White Health. "It is reassuring now five years later that in this very ill and elderly patient group facing a high likelihood of mortality, more patients treated with SAPIEN experienced sustained improvements in functional heart status and fewer repeat hospitalizations – two measures that signify an improvement in quality of life.

"This was the first study of its kind for transcatheter heart valves," said Mack. "The PARTNER Trial has historical significance in the development of TAVR and continues to provide the clinical community with important information about the durability and performance of the Edwards SAPIEN valves."

The Edwards family of SAPIEN valves are the most studied transcatheter heart valves in history and have been used in the treatment of more than 85,000 patients globally.

The prospective, multicenter PARTNER Trial provided the initial experience with transcatheter aortic valve replacement in the United States. The trial documented the outcomes of 358 inoperable aortic stenosis (AS) patients treated at 21 centers between 2007 and 2009. In Cohort B of The PARTNER Trial, inoperable patients with severe, symptomatic AS were evenly randomized to receive either transfemoral TAVR with the SAPIEN valve or standard therapy, which included balloon aortic valvuloplasty or medical management of symptoms. The one- and two-year results from The PARTNER Trial were published in The New England Journal of Medicine.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com.

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

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SOURCE Edwards Lifesciences Corporation