IRVINE, CA, Nov 06 (MARKET WIRE) --
Edwards Lifesciences Corporation (NYSE: EW), the world leader in the
science of heart valves, today announced the first successful Japanese
implants of a transcatheter aortic heart valve using its Edwards SAPIEN
valve.
The transfemoral and transapical valve implantations were performed by
Osaka University last month in preparation for Osaka's Senshin-Iryo
application submission to the Japanese Ministry of Health, Labour and
Welfare.
"We are continuing the momentum of Edwards' global transcatheter heart
valve program with the first human implants in Japan. We look forward to
providing this important treatment option to more Japanese patients and
continuing to demonstrate very strong patient outcomes with the Edwards
SAPIEN valve," said Michael A. Mussallem, Edwards' chairman and CEO.
The Edwards SAPIEN valve was approved for sale in Europe in late 2007. It
has been used in the treatment of thousands of high-risk patients in both
commercial and clinical trial environments, and evaluated as part of nine
rigorous scientific studies now complete or underway. In the United
States, it is being studied as part of the world's only randomized,
pivotal clinical trial of a transcatheter aortic valve.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves
and hemodynamic monitoring, with more than five decades of experience in
partnering with clinicians to develop life-saving innovations.
Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular
disease with its market-leading heart valve therapies, and critical care
and vascular technologies, which are sold in approximately 100 countries.
The company's global brands include Carpentier-Edwards, Cosgrove-Edwards,
Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz.
Additional company information can be found at http://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 can
sometimes be identified by the use of words such as "may," "will,"
"should," "anticipate," "believe," "plan," "project," "estimate,"
"expect," "intend," or other similar expressions and include, but are not
limited to, the timing and progress of clinical studies relating to the
company's transcatheter valve technologies and the market opportunity for
transcatheter technologies. 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 that
expressed or implied by the forward-looking statements. Factors that
could cause actual results or experience to differ materially from that
expressed or implied by the forward-looking statements 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,
2008.
Edwards is a trademark of Edwards Lifesciences Corporation. Edwards
Lifesciences, the stylized E logo, Carpentier-Edwards, Cosgrove-Edwards,
Edwards SAPIEN , FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz are
trademarks of Edwards Lifesciences Corporation and are registered in the
United States Patent and Trademark Office.
Media Contact:
Sarah Huoh
949-250-5070
Investor Contact:
David K. Erickson
949-250-6826
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