Edwards Receives Reimbursement Approval for Sapien XT Valve in Japan
IRVINE, CA -- (Marketwired) -- 08/21/13 -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that Japan's
Central Social Insurance Medical Council (Chuikyo) has approved the
recommendation by the Japanese Ministry of Health, Labor and
Welfare's (MHLW) expert review panel to provide reimbursement for the
Edwards SAPIEN XT transcatheter aortic heart valve. The reimbursement
is scheduled to go into effect on October 1.
This decision follows regulatory approval of the SAPIEN XT valve in
June. With this approval, Chuikyo established a reimbursement of 4.53
million yen (approximately $46,000 at current exchange rates) for
when the SAPIEN XT valve is used in the treatment of patients with
severe symptomatic aortic stenosis. The reimbursement rate for
medical devices in Japan covers the cost of the device as well as
taxes, certain hospital fees and distribution expenses.
"We are very pleased that the Japanese government has moved swiftly
to provide reimbursement for the SAPIEN XT valve, to enable the
country's clinicians to treat transcatheter aortic valve replacement
patients with the latest therapy," said Larry L. Wood, Edwards'
corporate vice president, transcatheter heart valves.
The SAPIEN XT valve is the first commercially available transcatheter
valve in Japan. 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 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 not limited to, the timing and potential
impact of the reimbursement decision. 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 or changes in
reimbursement. 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 and Edwards SAPIEN XT are trademarks of Edwards Lifesciences
David K. Erickson
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