LONDON, Sept. 19, 2016 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced that it has received CE
Mark to expand use of the Edwards SAPIEN 3 transcatheter heart
valve for the treatment of patients suffering from severe,
symptomatic aortic stenosis who are at intermediate risk for
open-heart surgery.
"This expanded intermediate-risk indication allows for the
treatment of even more patients whose only previous option was an
open-heart surgical procedure," said Prof. Helge Möllmann, Director, Clinic for Internal
Medicine (Cardiology) at St. Johannes Hospital, Dortmund, Germany. "I am encouraged by the
adoption of the position paper of the German Cardiac Society that
recommends the use of transcatheter aortic valve implantation
(TAVI) in intermediate-risk patients based on growing clinical
evidence."
For patients with severe aortic stenosis who are at intermediate
risk for an open-heart surgical procedure, TAVI using the
Edwards SAPIEN 3 valve has been shown1 to
demonstrate outcomes that are superior to surgery at one year on a
composite primary endpoint of mortality, stroke and moderate or
severe aortic regurgitation.
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 valve was first approved in
Europe in January
2014 for the treatment of patients with severe, symptomatic
aortic stenosis who are at high-risk for open heart surgery. The
U.S. Food and Drug Administration approved the SAPIEN 3 valve for
the treatment of intermediate-risk patients in August 2016.
(1)
|
Thourani V et al.
Transcatheter aortic valve replacement versus surgical valve
replacement in intermediate-risk patients: a propensity score
analysis. The Lancet 2016;1-8.
|
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 Prof.
Möllmann and statements regarding expected product benefits,
procedural outcomes and changes to guidelines. 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 longer term clinical experience,
unexpected changes or delays related to product supply, potentials
for unexpected regulatory, clinical 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, are trademarks of
Edwards Lifesciences Corporation. All other trademarks are the
property of their respective owners.
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SOURCE Edwards Lifesciences Corporation