Edwards Lifesciences Receives Approval for SAPIEN XT in Japan

Edwards Lifesciences Receives Approval for SAPIEN XT in Japan 
IRVINE, CA -- (Marketwired) -- 06/24/13 --  Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that the Japanese
Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards
SAPIEN XT valve, making it the country's first commercially available
transcatheter aortic heart valve.  
The company expects to obtain reimbursement approval from MHLW by
year's end, and will initiate a full launch in Japan immediately
thereafter. 
"We know that severe aortic stenosis is undertreated in Japan, and
patients urgently need access to the latest therapy. We are pleased
that Japanese regulators took a progressive approach to the approval
of SAPIEN XT, focusing their review process on the valve that is the
market leader in Europe, rather than our previous generation
transcatheter valve," said Larry L. Wood, Edwards' corporate vice
president, transcatheter valve replacement. "We are committed to a
disciplined launch of this therapy, which includes a robust training
program for Japanese heart teams." 
In patients who are not good candidates for surgical aortic valve
replacement, the Edwards SAPIEN XT valve can be implanted via a
catheter into a beating heart. The device can be delivered through
the transfemoral artery in the leg or transapically, through a small
incision between the ribs. The valve's bovine pericardial tissue
leaflets are based on Edwards' clinically proven surgical heart
valves. 
The Edwards SAPIEN XT valve has been studied in the treatment of
thousands of patients in both commercial and clinical trial
environments. The clinical study in Japan was conducted in leading
cardiovascular centers Osaka University Hospital (Osaka), Sakakibara
Heart Institute (Tokyo) and Kurashiki Central Hospital (Okayama).  
Additionally, the valve has been used widely by clinicians throughout
Europe since its commercial launch in 2010. In the United States, the
SAPIEN XT valve is not commercially available; it is an
investigational device being studied as part of a randomized, pivotal
clinical trial. 
About Edwards Lifesciences
 Edwards Lifesciences is the global leader
in the science of heart valves and hemodynamic monit
oring. 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, Mr. Wood's statements,
and statements regarding anticipated timing of reimbursement approval
and full launch in Japan. 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 delays our outcomes for
reimbursement approval, as well as unexpected manufacturing, 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 and Edwards SAPIEN
XT are trademarks of Edwards Lifesciences Corporation. 
Media Contact: 
Sarah Huoh
949-250-5070 
Investor Contact:
David K. Erickson
949-250-6826 
 
 
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