IRVINE, Calif., Jan. 15, 2016 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced U.S. Food and Drug
Administration approval for an expanded indication study of its
most advanced transcatheter aortic heart valve, the Edwards SAPIEN
3 valve. The investigational device exemption (IDE) study
will enroll elderly patients with severe, symptomatic aortic
stenosis (AS) who have been determined by a heart team to be at low
risk for mortality if they were to undergo surgical aortic valve
replacement.
Patients enrolled in the new PARTNER III Trial will be
randomized to receive either the SAPIEN 3 valve or open surgical
valve replacement. To be eligible for the trial, patients
must be at least 65 years old, exhibit symptoms of severe AS and be
determined by a heart team to have a surgical risk score of less
than 4 percent per the Society of Thoracic Surgeons adult cardiac
surgery risk calculator. The trial is a non-inferiority study
with a one-year composite endpoint that includes death, stroke and
rehospitalization. Enrollment of approximately 1,300 patients
at up to 50 sites is expected to begin during the second
quarter. The trial will also include a 400-patient sub-study
using advanced imaging to evaluate leaflet motion in tissue heart
valves.
"If this trial is successful, it will allow heart teams to
choose a treatment approach that is best suited to every patient's
individual need. We are pleased to begin this important study
of the SAPIEN 3 transcatheter valve to evaluate its safety and
effectiveness in a broader group of elderly patients suffering from
this deadly disease," said Larry L.
Wood, Edwards' corporate vice president, transcatheter heart
valves.
The SAPIEN 3 valve was approved in the
United States in 2015 for the treatment of high-risk
patients suffering from severe, symptomatic
AS.
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 at
@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, Mr. Wood's statements
and statements regarding expected timing, scope and outcomes of the
clinical trial. 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 clinical trial, unanticipated outcomes of the trial or
longer term clinical experience with the product, or unanticipated
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, 2014. These
filings, along with important safety information about our
products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN 3, PARTNER, SAPIEN and SAPIEN 3 are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation