IRVINE, Calif., March 2, 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 to expand use of the Edwards SAPIEN XT
transcatheter heart valve for pulmonic valve replacement
procedures. The approval enables the treatment of adult and
pediatric patients who suffer from either a narrowed pulmonary
valve or moderate or greater pulmonary regurgitation caused by
congenital heart disease.
"U.S. approval of the SAPIEN XT valve for pulmonic procedures
provides an important, minimally invasive treatment option for a
small group of patients who typically face the burden of multiple
open-heart surgeries, oftentimes beginning at birth or during
childhood. As risks increase with each open-heart surgery, a
non-surgical option can help them receive treatment, recover and
return to normal activities sooner," said Larry L. Wood, Edwards' corporate vice
president, transcatheter heart valves.
FDA approval of the Edwards SAPIEN XT valve for pulmonic
procedures was supported by data from the multicenter COMPASSION
clinical trial and additional clinical data from Europe. As
previously indicated, the commercial opportunity related to this
approval is small and is factored into 2016 financial
expectations.
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 the Company's financial guidance for
2016. 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
manufacturing, quality or regulatory delays or issues. These and
other additional 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. These filings, along with important safety information
about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, COMPASSION,
Edwards SAPIEN, Edwards SAPIEN XT, SAPIEN and SAPIEN XT are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation