Edwards Receives IDE for US Clinical Trial of SAPIEN 3 Transcatheter Valve

Edwards Receives IDE for US Clinical Trial of SAPIEN 3 Transcatheter Valve 
IRVINE, CA -- (Marketwired) -- 08/05/13 --  Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that it has
received conditional Investigational Device Exemption (IDE) approval
from the U.S. Food and Drug Administration (FDA) to initiate a
clinical trial of its Edwards SAPIEN 3 transcatheter aortic heart
valve and accessories. 
The trial will study the SAPIEN 3 valve in the treatment of high-risk
and inoperable patients with severe symptomatic aortic stenosis. It
will enroll up to 500 patients treated with one of three delivery
techniques: the transfemoral approach through an incision in the leg,
the transapical route between the ribs or the transaortic approach
through a small incision in the chest and aorta. Edwards anticipates
that the trial will have a one-year composite endpoint compared to
previous SAPIEN valves. 
"We're very excited to have the opportunity to initiate a U.S. study
of the SAPIEN 3 valve. This valve builds on the SAPIEN platform and
provides new features designed to benefit patients and enhance ease
of use, such as a lower profile, a fabric cuff intended to reduce
paravalvular leak and new delivery systems," said Larry L. Wood,
corporate vice president, transcatheter heart valves. "We appreciate
the FDA's efforts to allow initiation of this trial in a timely way,
providing U.S. patients with access to our most advanced
transcatheter system." 
The Edwards SAPIEN 3 valve is an investigational device and is not
available commercially 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
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 no
t limited to, Mr. Wood's statements,
and statements regarding parameters and expected outcomes of the
clinical trial. 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, unexpected delays in the clinical
trial, unanticipated outcomes of, or changes to, the trial, or
quality 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, 2012. 
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN,
SAPIEN, Edwards SAPIEN 3 and SAPIEN 3 are trademarks of Edwards
Lifesciences Corporation. 
Media Contact: 
Sarah Huoh
Investor Contact: 
David K. Erickson
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