IRVINE, Calif., Feb. 15, 2018 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced it has received CE Mark
for its self-expanding CENTERA valve for severe, symptomatic aortic
stenosis patients at high risk of open-heart surgery. The Edwards
CENTERA valve is repositionable and retrievable and can be
delivered through a low-profile, 14-French, motorized delivery
system. It is uniquely packaged with the valve fully pre-attached
to the delivery system, which facilitates simple and rapid device
preparation.
"With the Edwards CENTERA valve, European clinicians and their
patients may now benefit from a self-expanding TAVR option that has
demonstrated exceptional clinical safety and performance outcomes
in the high surgical risk population," said Didier Tchétché, M.D.,
of Clinique Pasteur in Toulouse,
France. "Enhanced design features of the CENTERA valve,
including a motorized handle that enables stable valve deployment,
allow for a simpler procedure with compelling outcomes."
European certification of the CENTERA valve was based on the
CENTERA-EU Trial, which enrolled 203 high-risk patients at 23
centers in Europe, Australia and New
Zealand. Study results presented at EuroPCR 2017
demonstrated high survival rates (99 percent) and low rates of
disabling stroke (2.5 percent) and new permanent pacemaker (4.9
percent) at 30 days. In addition, there was a low 0.6 percent rate
of moderate paravalvular leak among patients, and zero incidents of
severe paravalvular leak. All patients in the study were treated
via the transfemoral access route with the majority under conscious
sedation.
"Edwards is committed to partnering with clinicians to offer
differentiated, best-in-class technologies for transcatheter heart
valve therapy," said Larry L. Wood,
Edwards' corporate vice president, transcatheter heart valves.
"European certification of the CENTERA valve provides a meaningful
treatment option for high-risk TAVR patients when their heart team
recommends a self-expanding device."
The CENTERA valve is not approved for commercial sale in the
U.S.
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, statements by Mr. Wood
and Dr. Tchétché and statements regarding future benefits and
expected outcomes with the valve. 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 the roll-out 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 longer-term clinical experience, or
unexpected changes or delays related to regulatory clearance,
reimbursement, product manufacturing or clinical practice. 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. Our filings, along with
important product safety information, are available
at www.Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
CENTERA 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