PARIS, May 17, 2017 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced late-breaking data at
EuroPCR 2017 demonstrating excellent clinical outcomes for
transcatheter aortic valve replacement (TAVR) patients treated with
the Edwards CENTERA valve. These new 30-day results are the first
data presented on the self-expanding Edwards CENTERA valve.
For severe, symptomatic aortic stenosis patients at high risk of
open-heart surgery, the Edwards CENTERA valve demonstrated a very
high survival rate of 99 percent, a low 2.5 percent disabling
stroke rate and a 4.9 percent permanent pacemaker rate – the lowest
rate ever reported in a multi-center trial for a self-expanding
valve. Additionally, there was a low 0.6 percent rate of moderate
paravalvular leak among patients, and no severe paravalvular leak.
All 203 patients in the study were treated via the transfemoral
access route with the majority (174 patients) under conscious
sedation.
The Edwards CENTERA valve is repositionable and retrievable and
can be delivered through a low-profile 14-French delivery system
that features a motorized handle that results in stable valve
deployment. The valve is uniquely packaged – fully pre-attached
which facilitates simple and rapid device preparation.
"The Edwards CENTERA valve demonstrates extremely favorable
early clinical safety and performance outcomes in the high surgical
risk TAVR population," said Didier Tchétché, M.D., of Clinique
Pasteur in Toulouse, France, who
presented the data. "In addition to excellent patient outcomes, the
valve also offers several unique features and an innovative tissue
design, all of which simplify the procedure for clinicians."
CENTERA-EU Trial patients were enrolled in 23 centers in
Europe, Australia and New
Zealand and will be followed for five years. The Edwards
CENTERA valve is an investigational device not yet available
commercially in any country. Edwards anticipates it will receive CE
Mark approval for the CENTERA valve during the fourth quarter.
Dr. Tchétché 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, Dr. Tchétché's
statements and statements regarding expected future product
benefits and results. 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
longer term clinical experience with the product; or unanticipated
quality, manufacturing 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, 2016.
These filings, along with important safety information about our
products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, and CENTERA
are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation