Edwards SAPIEN 3 TAVR Demonstrates Significant Health Status Improvements for Low-Risk Patients
SAN FRANCISCO, Sept. 29, 2019 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced new data demonstrating early and sustained health status advantages for severe aortic stenosis (AS) patients at low surgical risk treated with the Edwards SAPIEN 3 valve. Study results were presented as a late-breaking clinical trial at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and simultaneously published online to the Journal of the American College of Cardiology.
The new 1-year data, involving approximately 1,000 patients enrolled in the PARTNER 3 Trial, showed significant improvements in health status as well as overall physical and mental well-being after treatment with either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 valve or surgical aortic valve replacement.
When the treatment strategies were compared, TAVR patients improved more rapidly than surgery patients as demonstrated by a difference of 16.0 points between the groups in Kansas City Cardiomyopathy Questionnaire Overall Summary Scores (KCCQ-OS) at 1 month (p < 0.001). While similar findings of early health status benefit with TAVR have been seen in prior studies of higher risk AS patients, this study also observed a sustained health status benefit of TAVR compared with SAVR at later time points of 6 months (2.6 points (p = 0.002)) and 1 year (1.8 points (p = 0.03)). Furthermore, when mortality and the extent of quality of life improvement were evaluated together, the benefit of transfemoral TAVR with the SAPIEN 3 valve compared with surgery persisted through 1 year.
"Taken together with the clinical outcomes of the PARTNER 3 Trial, these health status findings further support the use of TAVR in patients with severe aortic stenosis at low surgical risk," said Suzanne J. Baron, M.D., M.Sc., director of interventional cardiology research at Lahey Hospital and Medical Center.
The U.S. Food and Drug Administration approved the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves for low-risk patients last month, based on data from the landmark PARTNER 3 Trial, and the launch is underway. In the PARTNER 3 Trial, TAVR with the SAPIEN 3 system achieved superiority, with a 46 percent reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke and rehospitalization at one year.
"SAPIEN 3 TAVR is a proven technology with demonstrated clinical and health status superiority for these low-risk patients," said Larry Wood, Edwards' corporate vice president of transcatheter aortic valve replacement. "This study further demonstrates both early and late benefits of TAVR that are important to patients who lead active, productive lives."
The SAPIEN 3 TAVR system 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 and critical care 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. Baron and Mr. Wood 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 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 outcomes after more expanded clinical experience, unexpected changes or delays related to product supply, potentials for unexpected regulatory or quality developments, competitive dynamics, or unexpected delays or changes in patient access, litigation or clinician acceptance. 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, 2018.
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