LONDON, Nov. 27,
2022 /PRNewswire/ -- Edwards Lifesciences
Corporation (NYSE: EW) announced that one-year results on patients
treated in the single-arm, prospective, global, multi-center
TRISCEND study of the company's EVOQUE transcatheter tricuspid
valve replacement system demonstrated favorable safety, efficacy
and quality-of-life outcomes. The data were presented during the
late-breaking trials session at PCR London Valves 2022.
Patients enrolled in the TRISCEND study had symptomatic moderate
or greater functional or degenerative tricuspid regurgitation (TR),
despite optimal medical therapy. The TRISCEND study enrolled
176 patients, representing the largest dataset among transcatheter
tricuspid valve replacement therapies.
Following positive 30-day and 6-month results, the one-year
outcomes demonstrated:
- High survival of 90.1% and high freedom from heart failure
hospitalization at 88.4%;
- Significant and sustained TR reduction, with 97.6% of patients
with mild or trace TR (n=84);
- Significantly improved functional and quality-of-life outcomes,
with 93% of patients in NYHA Class I or II compared to 26% at
baseline (n=89) and a 26-point increase in KCCQ score over baseline
(n=102).
"Tricuspid regurgitation is prevalent, undertreated and has a
significant impact on patients' quality of life. With most TR
patients at high risk for surgery, there is a great need for an
approved transcatheter valve replacement treatment option,"
said Prof. Didier Tchetche, MD, Clinique
Pasteur, Toulouse, France and
TRISCEND study co-primary investigator. "The one-year results for
patients who received the EVOQUE tricuspid valve replacement as
part of the TRISCEND study provide important support for our
confidence in this therapy as an option for patients who suffer
from tricuspid regurgitation."
"We are encouraged by the sustained safety and performance
outcomes demonstrated by the EVOQUE system at one year, as it
represents a meaningful therapy in our portfolio of transcatheter
therapies being developed to help improve the quality-of-life for
patients with tricuspid and mitral valve diseases," said
Bernard J. Zovighian, Edwards'
corporate vice president, transcatheter mitral and tricuspid
therapies. "Edwards' eight data presentations included in this
year's PCR London Valves program deliver on our long-term
investment in innovation and clinical evidence generation to meet
the needs of patients and mark a new era for our company."
Additional presentations in the PCR London Valves 2022 program
for Edwards' portfolio of transcatheter mitral and tricuspid
therapies include:
- Transcatheter Tricuspid Valve Repair: The CLASP II TR Trial
Roll-in Cohort (Nov. 27)
-
- Late-Breaking Trial Presenter: Michael
Young
- Transcatheter Tricuspid Annular Reduction: The TriBAND Study
1 Year Outcomes (Nov. 27)
-
- Late-Breaking Trial Presenter: Volker
Rudolph
- The CLASP IID Trial: A Randomized Comparison of
Transcatheter Edge-to-Edge Repair Devices for Degenerative Mitral
Regurgitation in Prohibitive Surgical Risk Patients
(Nov. 28)
-
- Late-Breaking Trial Presenter: Jörg Hausleiter
- The CLASP IID Registry: A Prospective Registry for
Transcatheter Edge-to-Edge Repair in Patients with Anatomically
Complex Degenerative Mitral Regurgitation (Nov. 28)
-
- Presenter: Jörg Hausleiter
- Three-year Outcomes for Transcatheter Mitral Repair from the
CLASP Study (Nov. 28)
-
- Presenter: Konstantinos Spargias
- One-year Outcomes for Transcatheter Mitral Repair from the
MiCLASP Study (Nov. 28)
-
- Transcatheter Repair of Tricuspid Regurgitation: TriCLASP
Study Six-month Follow-up (Nov.
29)
-
- Presenter: Niklas Schofer
The EVOQUE valve replacement system is an investigational device
and is not available for sale in any country. The TRISCEND II
randomized pivotal trial is currently underway. The EVOQUE system
is one of several transcatheter replacement or repair therapies in
development by Edwards as part of the company's commitment to
transform the treatment of patients with mitral and tricuspid valve
disease, supported by robust contemporary clinical evidence.
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, 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, 2021, and its Quarterly
Reports on Form 10-Q for the quarters ended March 31,
June 30, and September 30, 2022. These filings, along with
important safety information about our products, may be found at
Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, CLASP,
EVOQUE, MiCLASP, TriBAND, TriCLASP, 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