IRVINE, Calif., June 8, 2020 /PRNewswire/ -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in patient-focused
innovations for structural heart disease and critical care
monitoring, today announced that it has received Chinese regulatory
approval for the Edwards SAPIEN 3 transcatheter heart valve for the
treatment of patients suffering from severe, symptomatic aortic
stenosis (AS) at high risk for or unable to undergo open-heart
surgery.
"Now, in China, patients
diagnosed with severe AS have the option of a shorter procedure
with excellent clinical outcomes, including a more rapid recovery
than open-heart surgery," said Prof. Junbo Ge, MD, academician of
the Chinese Academy of Sciences, chairman, Shanghai Institute of
Cardiovascular Diseases and director, Department of Cardiology,
Zhongshan Hospital, Fudan University.
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 transcatheter heart valves. The SAPIEN TAVR
valves are the most widely studied transcatheter valves, with more
than 30,000 patients treated in clinical trials and registries in
over 65 countries around the world. The approval for high-risk and
extreme-risk patients in China was
supported by the China SAPIEN 3 study, which complements a highly
robust set of clinical outcomes from three randomized controlled
PARTNER studies, along with excellent real-world results.
"This approval marks a major milestone for Chinese physicians
and their patients living with severe AS in need of alternatives to
open-heart surgery," said Larry L.
Wood, Edwards' corporate vice president, transcatheter
aortic valve replacement. "Edwards is proud to introduce this
technology, which has demonstrated successful outcomes for patients
worldwide, into China. We look
forward to partnering with hospitals throughout China to introduce this therapy through our
comprehensive, globally proven training program."
The valve, available in 20mm, 23mm, 26mm and 29mm sizes, is
approved by the National Medical Products Administration for
treating high-risk patients in China. To date, more than 650,000 patients
around the world have benefitted from TAVR.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the
global leader of patient-focused medical innovations for structural
heart disease and critical care monitoring. We are driven by a
passion for patients, dedicated to improving and enhancing lives
through partnerships with clinicians and stakeholders across the
global healthcare landscape. For more information, visit
Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter
and YouTube.
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 Prof. Ge
and Mr. Wood and statements regarding expected product and program
benefits and clinical 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. Statements of past performance, efforts, or results
about which inferences or assumptions may be made can also be
forward-looking statements and are not indicative of future
performance or results; these statements can be identified by the
use of words such as "continued," "transform," "develop,"
"preliminary," "initial," diligence," "industry-leading,"
"compliant," "indications," or "early feedback" or other forms of
these words or similar words or expressions or the negative
thereof. Investors are cautioned not to unduly rely on such
forward-looking statements.
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. Other
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, 2019
and the Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020. 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, Edwards SAPIEN 3, SAPIEN, and SAPIEN 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