Health & Fitness
Health and Fitness
Health and Fitness
Tue, November 10, 2009
Mon, November 9, 2009
Fri, November 6, 2009 First Transcatheter Valve Cases in Japan Performed With Edwards SAPIEN Valve
IRVINE, CA--(Marketwire - November 6, 2009) - Edwards Lifesciences Corporation (
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.
