IRVINE, Calif., May 19, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
that in consultation with trial investigators, the company has
voluntarily implemented a temporary pause on enrollment in its
FORTIS clinical program. We observed evidence of valve
thrombosis that we believe warrants additional investigation.
We are working closely with the trial investigators and Heart
Teams to gather additional information in this early study of
transcatheter mitral valve replacement therapy.
To date, we have treated more than 20 patients globally with the
FORTIS valve, all of whom had symptomatic mitral regurgitation and
who were either compassionate cases or in one of our high-risk
registries. While it is still very early in the program, and
we anticipated that optimizing this therapy would be challenging,
we are continuing to learn which patients may benefit. We
remain committed to and are encouraged by the early experience in
transcatheter mitral valve replacement therapy.
The FORTIS valve is not approved for sale in any country.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of
heart valves and hemodynamic monitoring. Driven by a passion
to help patients, the company partners with clinicians to develop
innovative technologies in the areas of structural heart disease
and critical care monitoring, enabling them to save and enhance
lives. Additional company information can be found at
www.edwards.com.
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 regarding
the future of transcatheter mitral replacement therapy and the
temporary pause in enrollment in the FORTIS valve clinical program.
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 actual 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 outcomes
after more expanded and in depth clinical experience and
follow up, as well as other factors affecting the success of the
program and of the therapy, such as unexpected developments in
regulatory status or quality. 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.
Edwards, Edwards Lifesciences, the stylized E logo and FORTIS
are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation