IRVINE, Calif., Aug. 18, 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 (FDA) approval to expand use of the Edwards SAPIEN 3
transcatheter heart valve for the treatment of patients suffering
from severe, symptomatic aortic stenosis who have been determined
by a Heart Team to be at intermediate risk for open-heart
surgery. The SAPIEN 3 valve is the first transcatheter aortic
valve replacement (TAVR) therapy to obtain this indication in
the United States.
"The SAPIEN 3 valve has set a new standard for performance and
patient outcomes with aortic valve replacement," said Vinod Thourani, M.D., co-director of
Emory Heart and Vascular Center's
Structural Heart and Valve Center and professor of
cardiothoracic surgery at Emory University
School of Medicine. "The clinical outcomes of 1.1 percent
mortality and 1.0 percent disabling stroke at 30 days in this
intermediate-risk population treated with the SAPIEN 3 valve are
changing the paradigm of how we treat patients with aortic
stenosis."
Thourani is the co-principal investigator of the SAPIEN 3 valve
study.
"The intermediate-risk approval of the SAPIEN 3 valve is a major
milestone, since it provides a less-invasive therapy that has
demonstrated better outcomes for aortic valve patients, and is
supported by the largest and rigorous comparative body of evidence
for the treatment of aortic stenosis," said Larry L. Wood, Edwards' corporate vice
president, transcatheter heart valves.
The SAPIEN 3 valve intermediate-risk approval was based on data
from a cohort of the PARTNER II Trial, which studied 2,005
intermediate-risk patients at 51 sites in the United States and Canada. The study demonstrated that patients
treated with the SAPIEN 3 valve experienced clinically significant
improvements for the composite primary endpoint of mortality,
stroke and moderate or severe aortic regurgitation at one year as
compared to those treated with surgery. The data were
presented in April at the American College of Cardiology's
65th Annual Scientific Session and simultaneously
published in The Lancet.
The expanded intermediate-risk indication granted by the FDA
enables Heart Teams to treat patients with the SAPIEN 3 valve who
they determine to have a predicted risk of surgical mortality of
greater than or equal to 3 percent at 30 days, based on the Society
of Thoracic Surgeons (STS) risk score and other clinical
co-morbidities unmeasured by the STS risk calculator.
The SAPIEN 3 valve builds on Edwards' decades of experience in
the development of tissue heart valves, and the proven benefits of
the Edwards SAPIEN valves. The SAPIEN 3 valve was approved by the
FDA in June 2015 for the treatment of
patients with severe, symptomatic aortic stenosis who are at
high-risk for open heart surgery.
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 Dr.
Thourani and Mr. Wood and statements regarding expected product
benefits and procedural outcomes. 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 the roll-out and benefits of the technology 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 outcomes after more expanded clinical experience,
unexpected changes or delays related to product supply, potentials
for unexpected regulatory or quality developments, competitive
dynamics, litigation and customer acceptance. 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, 2015.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN 3, SAPIEN, SAPIEN 3, PARTNER and PARTNER II
are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation