IRVINE, Calif., July 27, 2016 /CNW/ -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in patient-focused
innovations for structural heart disease and critical care
monitoring, today announced that Health Canada has approved the
Edwards SAPIEN 3 transcatheter heart valve for the treatment of
patients living with severe, symptomatic aortic stenosis and at
high or greater risk for surgical aortic valve replacement.
The SAPIEN 3 valve builds on Edwards' decades of experience in
the development of tissue heart valves, and the proven benefits of
the Edwards SAPIEN valves. The new valve is available in sizes
20mm, 23mm, 26mm and 29mm.
"The SAPIEN 3 valve has set new standards in patient outcomes
and performance for heart valve replacement," said Dr. John Webb, director of interventional
cardiology and cardiac catheterization laboratories at St.
Paul's Hospital, Vancouver, and professor of cardiology
at the University of British
Columbia. "Supported by large, adjudicated clinical
experience demonstrating extremely low rates of mortality, stroke
and paravalvular leak at 30 days and 1 year, the SAPIEN 3 valve has
changed the paradigm for patients in need of heart valve
replacement."
The Edwards SAPIEN 3 valve has been commercially available in
Europe since 2014, and received
U.S. regulatory approval in 2015. The SAPIEN family of valves has
been used in the treatment of more than 150,000 patients
globally.
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, statements by Dr. Webb.
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 actual results and benefits of the technology 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, global economic conditions and customer 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, 2015.
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, and SAPIEN 3 are trademarks of Edwards Lifesciences
Corporation.
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SOURCE Edwards Lifesciences Corporation