Edwards Lifesciences Receives Approval for PERIMOUNT Mitral Heart
Valve in China
IRVINE, CA -- (Marketwire) -- 11/28/12 -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that it has
received approval from China's State Food and Drug Administration
(SFDA) for its Carpentier-Edwards PERIMOUNT Mitral Heart Valve, a
replacement heart valve made of bovine pericardial tissue.
"The PERIMOUNT Mitral Heart Valve provides an important therapeutic
option for mitral valve replacement, particularly for those patients
with lifestyle considerations that may not be compatible with the
lifelong blood-thinning medication required with mechanical heart
valves," said Shengshou Hu, M.D., president of Fuwai Hospital and
China National Heart Center. "This valve offers excellent
hemodynamics and established long-term durability, providing Chinese
surgeons with an important new, yet clinically established, treatment
for their patients suffering from mitral valve disease."
Designed for the treatment of mitral valve disease, the PERIMOUNT
Mitral Heart Valve was introduced into clinical use in 1984 and has
demonstrated long-term endurance, as reported in numerous
peer-reviewed studies. The valve is treated with the
Carpentier-Edwards ThermaFix process, the only anti-calcification
tissue treatment that targets both major calcium binding sites that
lead to tissue calcification. Edwards' family of PERIMOUNT
pericardial valves have been the world's most frequently implanted
valves for more than 30 years.
"The approval in China of our market-leading PERIMOUNT Mitral Heart
Valve represents a clinically significant advancement for patients in
the country suffering from mitral heart valve disease," said Donald
E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy.
"We are committed to bringing life-saving therapies that treat heart
valve disease to Chinese surgeons and their patients."
The Carpentier-Edwards PERIMOUNT Mitral Heart Valve was approved for
U.S. commercial distribution in 2000 and bears the CE mark for
countries in the European Union.
About Mitral Valve Disease
Mitral valve disease causes the valve's
leaflets to malfunction in one of two primary ways. When the mitral
valve is affected by mitral regurgitation, the leaflets weaken and
cannot close properly, so blood leaks backward within the heart; with
mitral stenosis, the leaflets stiffen due to the accumulation of
calcium and the opening of the valve narrows, restricting normal
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 that enable 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, Dr. Hu or Mr. Bobo's
statements and statements regarding potential clinical benefits of
the PERIMOUNT Mitral Valve. 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 or experience 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 clinical
outcomes following expanded clinical experience and unexpected market
developments. These and other 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, 2011.
Edwards, Edwards Lifesciences, the stylized E logo,
Carpentier-Edwards, PERIMOUNT and ThermaFix are trademarks of Edwards
Sarah Huoh or Janet Kim
David K. Erickson
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