IRVINE, Calif., June 5, 2017 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced it has received U.S. Food
and Drug Administration (FDA) approval for aortic and mitral
valve-in-valve procedures using the Edwards SAPIEN 3 transcatheter
heart valve. The SAPIEN 3 valve is the first transcatheter heart
valve approved in the U.S. for the treatment of both aortic and
mitral patients who are at high risk for a subsequent open-heart
surgery to replace their bioprosthetic valve.
"Expansion of the SAPIEN 3 device indication to include
valve-in-valve procedures is a meaningful advancement for patients
at high risk of an additional open-heart valve procedure,
particularly for those in need of a safe alternative for mitral
valve replacement," said Larry L.
Wood, Edwards' corporate vice president, transcatheter heart
valves.
This anticipated FDA approval of the indication expansion was
supported by real-world data collected from the Society of Thoracic
Surgeons and American College of Cardiology (STS/ACC) Transcatheter
Valve Therapy (TVT) Registry. The TVT Registry includes information
and outcomes on patients undergoing transcatheter valve replacement
and repair procedures in the United
States.
"This approval brings a safe and effective transcatheter therapy
to patients who would do very poorly with repeat open-heart
surgery," said John Carroll, M.D.,
professor of cardiology at the University of
Colorado School of Medicine and director of interventional
cardiology at the University of
Colorado Hospital, Denver
and member of the TVT Registry Steering Committee. "I am pleased to
see that the FDA recognizes the value of the high-quality evidence
generated by the STS-ACC TVT Registry and its ability to play an
important role in assessing 'real-world' clinical results in
specialty indications, such as valve-in-valve, and for particular
patient groups, such as those needing replacement of a
bioprosthetic mitral valve."
The Edwards SAPIEN 3 valve was approved by the FDA in 2015 for
severe, symptomatic aortic stenosis patients at high risk for
open-heart surgery, and, in 2016, received approval for the
treatment of patients who are at intermediate risk for open-heart
surgery. 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.
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 made by Mr.
Wood and Dr. Carroll. 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, unanticipated outcomes of
longer term clinical experience with the product, or unanticipated
quality, manufacturing or regulatory 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, 2016. 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, SAPIEN, and SAPIEN 3 are trademarks of
Edwards Lifesciences Corporation. All other trademarks are the
property of their respective owners.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/edwards-sapien-3-valve-receives-fda-approval-for-aortic-mitral-valve-in-valve-procedures-300468912.html
SOURCE Edwards Lifesciences Corporation