SAN
FRANCISCO, Oct. 26, 2023 /PRNewswire/ --
Edwards Lifesciences Corporation (NYSE: EW) today announced
successful results from TRISCEND II, a randomized controlled
pivotal trial designed to evaluate the safety and effectiveness of
the groundbreaking EVOQUE tricuspid valve replacement system with
optimal medical therapy (OMT) compared to OMT alone with 2:1
randomization.
The outcomes for the first 150 patients of the TRISCEND II trial
achieved the primary safety endpoint at 30 days and both co-primary
effectiveness endpoints at six months, demonstrating superiority to
OMT alone. Results from the TRISCEND II trial were presented as a
late-breaking clinical trial session at the 35th
Transcatheter Cardiovascular Therapeutics (TCT), the annual
scientific symposium of the Cardiovascular Research
Foundation.
Patients enrolled in the TRISCEND II trial had at least severe
tricuspid regurgitation (TR). The EVOQUE valve was
successfully implanted in 95.8 percent of patients and the trial
met all primary endpoints with:
- Major adverse event rate at 27.4 percent at 30 days;
- Significant TR grade reduction with 98.8 percent of patients
achieving ≤ moderate TR and 93.8 percent achieving ≤ mild TR at six
months; and
- Substantially superior quality-of-life and functional outcomes
at six months for the composite endpoint including KCCQ, NYHA and
6MWD for the EVOQUE system plus OMT over OMT alone.
"We are excited by the safety and effectiveness data from
the first 150 patients of the TRISCEND II pivotal trial," said
Susheel Kodali, MD, director,
Structural Heart and Valve Center at Columbia
University Irving Medical Center/New York-Presbyterian
Hospital and TRISCEND II Study Principal Investigator. "With
no predicate study of a novel transcatheter tricuspid valve
replacement, these data and outcomes give us great hope in the
EVOQUE system as an option to treat patients who are very sick and
have few effective therapeutic options."
An FDA Advisory Committee Meeting of the EVOQUE system is
expected in Jan. 2024, followed by an
anticipated US approval in mid-2024. In 2019, the EVOQUE system
received FDA Breakthrough Designation, which is designed to provide
patients with timely access to new devices for life-threatening or
irreversibly debilitating conditions. As a result, the TRISCEND II
trial was specifically designed to include a pre-specified analysis
of the first 150 patients enrolled to evaluate the safety and
effectiveness of the EVOQUE system. The full cohort of 400 patients
is enrolled. Earlier this month, the EVOQUE system received CE Mark
for the transcatheter treatment of eligible patients with TR.
"Patients suffering from severe tricuspid regurgitation endure
debilitating symptoms and poor quality of life and are desperate
for effective treatment, as evidenced by the rapid enrollment in
this trial," said Daveen Chopra,
Edwards' corporate vice president, transcatheter mitral and
tricuspid therapies. "These data build upon the promising
foundation of results previously published from the single-arm
TRISCEND study and add to our growing body of contemporary clinical
evidence that enables more patients in need to receive
treatment."
Edwards is committed to transforming the treatment of patients
with mitral and tricuspid valve disease, supported by robust
clinical evidence. The EVOQUE system is one of multiple
transcatheter repair or replacement therapies in development by
Edwards.
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, Twitter 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, Edwards
EVOQUE, EVOQUE, 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