SAN
FRANCISCO, Oct. 26, 2023 /PRNewswire/ --
Edwards Lifesciences Corporation (NYSE: EW) announced one-year
results from CLASP IID, the first randomized controlled trial that
directly compares two contemporary mitral transcatheter
edge-to-edge repair (TEER) therapies, as well as one-year results
from the CLASP IID registry. The studies confirm the clinical and
quality-of-life benefits of mitral regurgitation (MR) reduction
with the PASCAL system in a broad population of patients with
degenerative mitral regurgitation (DMR). Results from the CLASP IID
randomized trial and registry 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, and simultaneously
published in JACC: Cardiovascular Interventions.
Patients enrolled in the CLASP IID pivotal trial had significant
symptomatic DMR and were determined to be at prohibitive surgical
risk. Patients enrolled in the CLASP IID registry met those same
criteria yet were deemed ineligible for randomization. One-year
results from the CLASP IID randomized trial showed the PASCAL
system achieved:
- Freedom from major adverse events rate of 84.7 percent at one
year, and
- Significant and sustained MR reduction, with 95.8 percent of
patients achieving MR ≤2+ at one year.
Increasingly, the MR reduction goal with TEER is to achieve MR
≤1+ because contemporary evidence suggests reduced regurgitation
may correlate with improved long-term patient outcomes. At one
year, 77.1 percent of PASCAL patients in the trial achieved a MR
rate of ≤1+. The PASCAL system also showed sustained outcomes of
high survival, low heart failure hospitalization and meaningful
quality-of-life improvements.
"These data from the CLASP IID randomized trial and registry
further advance mitral edge-to-edge repair as an important
treatment option for a wide range of very sick patients who suffer
with debilitating symptoms," said Firas
Zahr, MD, director of Interventional Cardiology
and co-director of the Complex Heart Valve Program at Oregon Health
& Science University and CLASP IID Study Investigator.
"Patients receiving the PASCAL system experienced significant
improvements in functional capacity and quality of life that were
sustained for one year."
The CLASP IID trial is a prospective randomized controlled trial
comparing the safety and effectiveness of the PASCAL system to the
MitraClip system. Results were reported on 300 patients with 2:1
randomization (204 PASCAL / 96 MitraClip), with clinical events
committee and echo core lab adjudication. The CLASP IID registry
enrolled 98 patients. The trial and registry included 57 sites in
the US, Canada and Europe, with most clinical operators new to
using the PASCAL system and all having experience with the
MitraClip system.
"We are pleased that these one-year results affirm the safety
and effectiveness of the PASCAL system and the benefits of TEER for
this undertreated patient population," said Daveen Chopra, Edwards' corporate vice
president, transcatheter mitral and tricuspid therapies. "Growing
our body of clinical evidence in support of our patient-driven
therapies is a high priority at Edwards, and we are committed to
pursuing multiple pivotal trials in our efforts to transform
treatment for a broad population of patients in need."
As part of Edwards' continued commitment to building robust
real-world evidence, patients receiving the PASCAL Precision system
in the US are enrolled in a post-market registry for five years.
Additional ongoing studies of the PASCAL system include the
single-arm CLASP trial and European post-market MiCLASP registry.
The PASCAL Precision system is one of multiple transcatheter repair
or replacement therapies in development by Edwards and is approved
for degenerative mitral regurgitation in the US and Japan and has CE Mark for the treatment of
mitral degenerative and functional regurgitation, and tricuspid
regurgitation.
About TEER
Transcatheter Edge-to-Edge Repair (TEER) of
the mitral valve is used in the treatment of MR. TEER
approximates the anterior and posterior mitral valve leaflets by
grasping them with a clasping device in an approach similar to a
treatment developed in cardiac surgery called the Alfieri
stitch.
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, CLASP,
Edwards PASCAL, Edwards PASCAL Precision, MiCLASP, PASCAL, and
PASCAL Precision are trademarks of Edwards Lifesciences
Corporation. All other trademarks are the property of their
respective owners.
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SOURCE Edwards Lifesciences Corporation