TRISCEND II Trial Demonstrates Superior Clinical and Quality-of-life Benefits With Edwards EVOQUE System for Severe Tricuspid Regurgitation
30 Octubre 2024 - 9:00AM
Business Wire
Edwards Lifesciences Corporation (NYSE: EW) today announced that
the EVOQUE system demonstrated superiority compared to medical
therapy alone for the one-year primary endpoint of the TRISCEND II
trial. TRISCEND II is a randomized controlled pivotal trial
designed to study the groundbreaking EVOQUE transcatheter tricuspid
valve replacement (TTVR) system with optimal medical therapy (OMT)
compared to OMT alone with 2:1 randomization. The data, presented
during the late-breaking clinical trial sessions at the
Transcatheter Cardiovascular Therapeutics (TCT) meeting, included
the full cohort of 400 patients. TRISCEND II trial one-year primary
endpoint outcomes will be simultaneously published in The New
England Journal of Medicine, and TRISCEND II trial one-year
quality-of-life (QoL) outcomes will be simultaneously published in
the Journal of the American College of Cardiology.
Patients enrolled in the TRISCEND II trial had at least severe
tricuspid regurgitation (TR). The EVOQUE valve was successfully
implanted in 95.4 percent of patients, and of those who received
the valve, nearly all (95.3 percent) achieved almost complete TR
elimination with ≤ mild TR at one year, compared to 2.3 percent of
patients receiving OMT alone. These TR reductions were associated
with significant improvements in symptoms, function and QoL at one
year, with favorable numerical outcomes in mortality and heart
failure hospitalization.
“It is exciting to have the EVOQUE system available as a
treatment option for patients who are very sick and otherwise have
limited, if any, options,” said Susheel Kodali, MD, Avanessians
Professor of Medicine at Columbia University Vagelos College of
Physicians and Surgeons and director of interventional
echocardiography at the Structural Heart & Valve Center at New
York-Presbyterian/Columbia University Irving Medical Center and
TRISCEND II Study Principal Investigator. “The one-year outcomes
from the TRISCEND II trial demonstrate the benefits of this therapy
in these patients and the favorable trends in all-cause mortality
and heart failure hospitalization are encouraging to see. We are
pleased to see TTVR reach this stage after nearly a decade of
development.”
“The TRISCEND II trial results also demonstrated sustained
quality-of-life benefits for patients receiving the EVOQUE system,”
said Suzanne Arnold, MD, MHA, Professor of Medicine at the
University of Missouri-Kansas City (UMKC) School of Medicine, and
Clinical Scholar at Saint Luke's Mid America Heart Institute.
“Patients receiving TTVR with the EVOQUE system were twice as
likely to be alive with a good quality-of-life at one year,
compared with the control group.”
The EVOQUE system is approved for use in both Europe and the US,
making it the world’s first and only approved TTVR system. The
EVOQUE system includes four valve sizes (44mm, 48mm, 52mm and
56mm), with the 56mm valve recently approved in the US.
“Edwards’ commitment to innovation is inspired by the millions
of patients around the world suffering with debilitating symptoms
and poor quality-of-life as a result of structural heart diseases
and in desperate need of effective treatment options,” said Daveen
Chopra, Edwards’ corporate vice president, transcatheter mitral and
tricuspid therapies. “We are building a portfolio of transcatheter
repair and replacement technologies for both the mitral and
tricuspid valves, and we are dedicated to supporting those
therapies with world-class evidence like what is being generated
through the TRISCEND II trial.”
About Edwards
Lifesciences
Edwards Lifesciences is the leading global structural heart
innovation company, driven by a passion to improve patient lives.
Through breakthrough technologies, world-class evidence and
partnerships with clinicians and healthcare stakeholders, our
employees are inspired by our patient-focused culture to deliver
life-changing innovations to those who need them most. Discover
more at www.edwards.com and follow us
on LinkedIn, Facebook, Instagram 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.
We intend the forward-looking statements contained in this release
to be covered by the safe harbor provisions of such Acts. These
forward-looking statements can sometimes be identified by the use
of forward-looking words, such as “may,” “might,” “believe,”
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“aspire,” “confident” and other forms of these words and include,
but are not limited to, statements made by Mr. Chopra and
statements regarding expected product benefits, patient outcomes,
Edwards’ objectives, commitment and dedication in building a
portfolio of technologies and evidence supporting those
technologies, 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
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Forward-looking statements involve risks and uncertainties that
could cause results to differ materially from those expressed or
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factors as detailed in the company's filings with the Securities
and Exchange Commission. 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, TRISCEND, and TRISCEND II are trademarks of Edwards
Lifesciences Corporation. All other trademarks are the property of
their respective owners.
Many Columbia University Vagelos College of Physicians and
Surgeons physicians and scientists maintain relationships and
collaborate with external organizations to foster scientific
innovation and provide expert guidance.
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