SAN FRANCISCO, Sept. 29, 2019 /PRNewswire/ -- 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.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, SAPIEN, SAPIEN 3,
SAPIEN 3 Ultra, PARTNER, and PARTNER 3 are trademarks of Edwards
Lifesciences Corporation. All other trademarks are the property of
their respective owners. This statement is made on behalf of
Edwards Lifesciences Corporation and its subsidiaries.
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SOURCE Edwards Lifesciences Corporation