IRVINE, Calif., Dec. 28, 2018 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced that the SAPIEN 3 Ultra
system has received U.S. Food and Drug Administration (FDA)
approval for transcatheter aortic valve replacement in severe,
symptomatic aortic stenosis patients who are determined to be at
intermediate or greater risk of open-heart surgery.
"The advanced SAPIEN 3 Ultra system features enhancements
on the valve and a new delivery system to address the needs of both
patients and clinicians, building on our best-in-class performance
of SAPIEN 3 to further advance and improve patient care," said
Larry L. Wood, Edwards' corporate
vice president, transcatheter heart valves. "We look forward to
introducing the SAPIEN 3 Ultra system to U.S. patients."
The SAPIEN 3 Ultra system builds on Edwards' decades of
engineering and experience in the development of tissue heart
valves, and the proven benefits of the Edwards SAPIEN
valves.
"The Edwards SAPIEN 3 Ultra system provides meaningful
technology improvements that help further optimize the
transcatheter aortic valve replacement procedure, adding simplicity
and advancing patient care," said John
Webb, M.D., director of interventional cardiology and
cardiac catheterization laboratories at St. Paul's Hospital, Vancouver, and professor of cardiology at the
University of British
Columbia.
Dr. Webb 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, Mr.
Wood's and Dr. Webb's statements and statements regarding expected
product benefits and outcomes of the product launch.
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 delays or changes
in the product introduction, unanticipated outcomes of clinical
experience with the product following more extensive clinical
experience, or unanticipated manufacturing, legal, quality or
regulatory delays or issues. 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, 2017. These filings,
along with important safety information about our products, may be
found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo,
Edwards SAPIEN, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks
of Edwards Lifesciences Corporation and its affiliates. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation