IRVINE,
Calif., Oct. 19, 2023 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW) today announced the company's
EVOQUE tricuspid valve replacement system received CE Mark for the
transcatheter treatment of eligible patients with tricuspid
regurgitation (TR). The EVOQUE system is the world's first
transcatheter valve replacement therapy to receive regulatory
approval to treat TR.
"Innovating for unmet patient needs is at the center of
everything we do at Edwards, which makes us especially proud to
have received CE Mark for this first-of-its-kind transcatheter
tricuspid valve replacement therapy," said Daveen Chopra, Edwards' corporate vice
president, transcatheter mitral and tricuspid therapies. "With the
EVOQUE system's approval, in addition to our current PASCAL
tricuspid system, we are now able to provide a broader array of
much-needed treatment options for appropriate tricuspid disease
patients in Europe."
The EVOQUE system is comprised of a nitinol self-expanding
frame, intra-annular sealing skirt, and tissue leaflets made from
the same bovine pericardial tissue as the company's market-leading
heart valves. The EVOQUE valve will be available in three sizes,
all delivered through a low-profile transfemoral 28F system.
"The EVOQUE system is able to fully replace the tricuspid valve,
virtually eliminating tricuspid regurgitation in a wide range of
anatomies," said Prof. Philipp Lurz,
Director of Cardiology, University of Mainz, Germany and European Principal Investigator
for the TRISCEND II study. "The significant improvements in
patients' quality-of-life are remarkable, now offering a therapy to
many patients who previously had no treatment options."
One-year results on patients treated in the single-arm,
prospective, global, multi-center TRISCEND study of the EVOQUE
system were presented at PCR London Valves 2022 and demonstrated
favorable safety and effectiveness outcomes and significant
quality-of-life improvements. Key findings included high survival
(90.1%) and high freedom from heart failure hospitalization
(88.4%); significant and sustained TR reduction to mild or trace TR
(97.6%); and significantly improved functional and quality-of-life
outcomes (93% of patients in NYHA Class I or II compared to 26% at
baseline and a 26-point increase in KCCQ score over baseline).
The company will present results from the TRISCEND II
pivotal trial, studying the EVOQUE system, during a late-breaking
clinical trial session on Oct. 26 in
San Francisco at the
35th Transcatheter Cardiovascular Therapeutics (TCT),
the annual scientific symposium of the Cardiovascular Research
Foundation.
Patients with tricuspid valve disease suffer greatly with
symptoms ranging from debilitating to life-threatening with few
effective options for relief. Other transcatheter therapies in
Edwards' tricuspid portfolio with CE Mark approval include the
PASCAL Precision transcatheter repair system and the Cardioband
annular reduction system. The company does not yet have any
transcatheter therapies approved for treatment of the tricuspid
valve in the United States.
About Edwards Lifesciences
Edwards Lifesciences is the
global leader of patient-focused 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, X and YouTube.
This news release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
These forward-looking statements include, but are not limited to,
statements made by Mr. Chopra and statements regarding expected
product benefits, patient outcomes, objectives and expectations and
other statements that are not historical facts. 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. 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 as 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, 2022, and its Quarterly
Reports on Form 10-Q for the quarters ended March 31 and
June 30, 2023. These filings, along
with important safety information about our products, may be found
at Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Cardioband,
Edwards EVOQUE, EVOQUE, PASCAL, PASCAL Precision, and TRISCEND are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation
