IRVINE, Calif., Aug. 16, 2019 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced U.S. Food and Drug
Administration (FDA) approval to expand use of the Edwards SAPIEN 3
and SAPIEN 3 Ultra transcatheter heart valve systems to the
treatment of severe, symptomatic aortic stenosis (AS) patients who
are determined to be at low risk of open-heart surgery.
"The PARTNER 3 Trial demonstrated that low-risk patients treated
with the SAPIEN 3 TAVR experienced extraordinary outcomes with 1.0
percent rates of death or disabling stroke at one year, a short
length of stay and 96 percent discharged to home or self-care.
SAPIEN 3 is the only valve to achieve superiority over surgery
based on the prespecified primary endpoint," said Martin B. Leon, M.D., director of the Center for
Interventional Vascular Therapy at
NewYork-Presbyterian/Columbia
University Medical Center and professor of medicine at the
Columbia University College of Physicians and
Surgeons. "Today's FDA approval of SAPIEN 3 TAVR will expand
access to this proven therapy, which should be considered the
preferred treatment for the majority of low-risk severe AS
patients." Leon is the national co-principal investigator of the
PARTNER 3 Trial.
The SAPIEN 3 TAVR's low-risk approval was based on data from the
landmark PARTNER 3 Trial, an independently evaluated, randomized
clinical trial comparing outcomes between TAVR and open-heart
surgery. 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. The data were presented in March
at the American College of Cardiology's 68th Annual Scientific
Session and simultaneously published in the New England Journal
of Medicine.
"Severe AS is a debilitating disease that often goes undiagnosed
and is undertreated," said Larry L.
Wood, Edwards' corporate vice president, transcatheter
aortic valve replacement. "This approval is a significant milestone
and will allow all patients diagnosed with severe AS to be
considered for TAVR based on their individual preferences and
anatomical considerations versus traditional risk scoring."
The SAPIEN family of transcatheter heart valves have treated
hundreds of thousands of patients worldwide since 2007, when the
SAPIEN valve was first commercially approved in Europe. 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. This
low-risk approval covers the SAPIEN 3 and SAPIEN 3 Ultra valves in
all sizes.
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. Leon
and Mr. Wood and statements regarding expected product benefits and
procedural outcomes, as well as increased patient access and
treatment. 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