IRVINE, Calif., Nov. 6, 2021 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW) announced that results from a
clinical trial of the company's EVOQUE transcatheter tricuspid
valve replacement system demonstrated that favorable patient
outcomes were sustained at six months. Results from the TRISCEND
study, treating patients with tricuspid regurgitation, were
presented during the late-breaking clinical science session at the
33rd Transcatheter Cardiovascular Therapeutics (TCT), the annual
scientific symposium of the Cardiovascular Research Foundation.
Patients enrolled in the TRISCEND study had symptomatic,
moderate or greater functional or degenerative tricuspid
regurgitation (TR), despite optimal medical therapy. Following
positive 30-day outcomes that were presented earlier this year, the
6-month results (n=56) demonstrated significant TR reduction by
core laboratory assessment. Specifically, at 6 months:
- Significant reduction in TR severity, with 100 percent of
patients with none/trace or mild TR in 43 patients with paired
echocardiographic data available
- Significantly improved functional and quality-of-life outcomes,
including 89% of patients in NYHA Class I or II, and a 27-point
increase in KCCQ score over baseline
- High survival rate of 96%, and freedom from heart failure
hospitalization of 94%
"Severe tricuspid regurgitation is becoming increasingly
recognized to have a significant impact on quality of life and may
be a predictor of increased mortality. Unfortunately, most
patients with TR are at high risk for conventional surgery and
there currently are no approved transcatheter options in the US,"
said Susheel Kodali, MD,
Columbia University Irving Medical
Center and TRISCEND Study Principal Investigator. "The six-month
results that we have seen with patients enrolled in the TRISCEND
study who received the EVOQUE tricuspid valve replacement are truly
remarkable and very promising for patients who suffer from
tricuspid regurgitation."
"We are quite encouraged by these data, not only related to the
therapy and procedural success rates demonstrated by the EVOQUE
system, but also for the significant TR reduction and sustained
improvements in quality-of-life measures experienced by patients,"
said Bernard J. Zovighian, Edwards'
corporate vice president, transcatheter mitral and tricuspid
therapies. "Our goal is to lead the transformation of treatment for
this diverse and expansive population of tricuspid valve disease
patients. We are committed to building a strong body of evidence to
support emerging therapies like the EVOQUE system, which will
continue with our randomized pivotal trial, TRISCEND II, currently
underway."
The TRISCEND study is a prospective, single-arm, multicenter
study, designed to evaluate the safety and performance of the
transfemoral EVOQUE tricuspid valve replacement system in TR.
Results were reported on 132 patients enrolled, with 6-month
follow-up results on 56 patients. The study continues to enroll and
additional patient follow-up will take place at 1 year and annually
up to 5 years. The trial endpoints are device and procedural
success, a composite of major adverse events (MAEs) at 30 days and
TR reduction.
The EVOQUE valve replacement system is an investigational device
and is not available for sale in any country.
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. Zovighian and statements regarding expected
product benefits, patient outcomes, future plans related to the
product lines, 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, 2020, and its Quarterly
Reports on Form 10-Q for the quarter ended March 31, 2021 and
June 30, 2021. These filings, along
with important safety information about our products, may be found
at Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, 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