PARIS, May 22, 2019 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, announced strategic clinical and
regulatory milestones for its Edwards PASCAL transcatheter valve
repair system.
Today at the EuroPCR annual course in Paris, new 6-month data from the CLASP study
of the PASCAL system were presented by Konstantinos Spargias, M.D.,
from the Hygeia Hospital in Athens, Greece. Patients enrolled in the
CLASP study had clinically significant mitral regurgitation (MR)
despite optimal medical therapy. The results from treatment
with the PASCAL system demonstrated sustained positive outcomes at
six months, including 81 percent of patients with mild (1+) or
none/trace MR and 98 percent with <2+ MR, with echo core lab
adjudication. Patients experienced clinically and
statistically significant improvements in functional status,
exercise capability and quality of life sustained at six
months. These data build on the 30-day CLASP study results
presented last month at the German Society of Cardiology (DGK),
which also demonstrated significant reduction in MR and
improvements in quality of life measures. At 30 days, the
major adverse events rate was low at 6.5 percent, and there was no
incidence of stroke or myocardial infarction (MI).
In addition, the U.S. Food and Drug Administration (FDA) has
approved CLASP IIF, a prospective, multicenter, randomized,
controlled pivotal trial studying the PASCAL system. The trial is
designed to evaluate the safety and effectiveness of transcatheter
mitral valve repair with the Edwards PASCAL system compared with
the Abbott MitraClip device, for the treatment of
moderate-to-severe (3+) or severe (4+) functional mitral
regurgitation (FMR) in symptomatic heart failure patients.
The study is expected to begin enrolling in the next few
months. Edwards already has underway the CLASP IID U.S.
pivotal trial, which is currently enrolling patients with
symptomatic primary mitral regurgitation.
"Each of these milestones, including the positive CLASP study
results, the approval of the pivotal CLASP IIF trial and the
pivotal CLASP IID trial already enrolling, support our strategy to
lead and transform the treatment of patients with mitral valve
disease," said Bernard J. Zovighian,
Edwards' corporate vice president, transcatheter mitral and
tricuspid therapies. "We look forward to the ongoing
follow-up on these clinical and regulatory milestones to further
validate these early results."
The PASCAL system is one of multiple transcatheter repair or
replacement therapies under development by Edwards that are
designed to address mitral and tricuspid valve diseases. It
represents the culmination of 20 years of innovation by Edwards to
develop a novel, differentiated and advanced platform for patients
in need. The company is building on a long history of
knowledge, experience and commitment to advance transformative
therapies and develop a robust body of clinical evidence.
The PASCAL system received CE Mark and is available commercially
in Europe; it is not approved in
the United States.
About Edwards Lifesciences
Edwards Lifesciences, based
in Irvine, Calif., is the global leader in patient-focused
medical innovations for structural heart disease, as well as
critical care and surgical monitoring. Driven by a passion to
help patients, the company collaborates with the world's leading
clinicians and researchers to address unmet healthcare needs,
working to improve patient outcomes and enhance lives. For more
information, visit www.edwards.com and follow us on
Twitter @EdwardsLifesci.
This news release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. These forward-looking
statements include, but are not limited to, statements by Mr.
Zovighian, expectations for trial enrollment, and statements
regarding expected product benefits and the company's strategy to
lead and transform patient care. 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.
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, including but not limited to, unexpected delays or changes
in the product introduction, unanticipated outcomes of longer term
clinical experience with the product, or unanticipated
manufacturing, legal, quality or regulatory delays or issues. These
factors are 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, 2018.
These filings, along with important safety information about our
products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo and PASCAL
are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners. This
statement is made on behalf of Edwards Lifesciences Corporation
and/or its subsidiaries.
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SOURCE Edwards Lifesciences Corporation