Edwards SAPIEN XT Transcatheter Valve and Delivery Systems Receive CE Mark | Edwards Lifesciences
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`News releases
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`Edwards SAPIEN XT Transcatheter Valve and Delivery Systems Receive CE Mark
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`IRVINE, CA, March 02, 2010 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science
`of heart valves and hemodynamic monitoring, today announced that it has received CE Mark for its Edwards
`SAPIEN XT transcatheter aortic heart valve, as well as its NovaFlex transfemoral and Ascendra 2 transapical
`delivery systems.
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`The company is beginning a disciplined European launch of the new valve and the 18 French NovaFlex delivery
`system, and will expand the number of commercial sites utilizing the system throughout the year.
`
`The Edwards SAPIEN XT transcatheter valve enables doctors to replace failing aortic valves without major
`surgery. The leaet design of this new valve is modeled after Edwards' clinically proven aortic tissue valves and
`its cobalt chromium frame provides improved radial strength and, therefore, enhanced circularity. The Edwards
`SAPIEN XT valve with the NovaFlex transfemoral delivery system is designed to provide easy, precise, balloon-
`expandable delivery of the valve.
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`"The Edwards SAPIEN XT valve platform oers best-in-class valve performance with a low-prole delivery
`system," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "We are
`excited about the new platform and our continued leadership in this transformational technology."
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`As heart teams continue to gain clinical experience with the Edwards SAPIEN XT valve on the Ascendra 2
`transapical delivery system, Edwards will begin introducing that system commercially in Europe during the
`second quarter. The Ascendra 2 system features a reduced prole and is designed for improving ease-of-use
`when delivering the valve through a small incision between the ribs.
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`https://www.edwards.com/ns20100302
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`Edwards Lifesciences Corporation, et al. Exhibit 1028, p. 1 of 3
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`Edwards SAPIEN XT Transcatheter Valve and Delivery Systems Receive CE Mark | Edwards Lifesciences
`The Edwards SAPIEN XT valve is the second commercially available transcatheter valve in the Edwards SAPIEN
`product portfolio. Edwards is the only company to commercialize both transfemoral and transapical
`transcatheter aortic valve systems, which have been available in Europe since 2007. In the United States, the
`Edwards SAPIEN valve is an investigational device being studied as part of the world's only randomized, pivotal
`clinical trial of a transcatheter aortic valve and not yet available commercially.
`
`About Edwards Lifesciences
`Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more
`than ve 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
`(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 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 dicult 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
`reect events or circumstances after the date of the statement.
`
`Forward-looking statements involve risks and uncertainties that could cause actual results or experience to
`dier materially from that expressed or implied by the forward-looking statements. Factors that could cause
`actual results or experience to dier materially from that expressed or implied by the forward-looking
`statements are detailed in the company's lings with the Securities and Exchange Commission including its
`Annual Report on Form 10-K for the year ended December 31, 2009.
`
`Edwards, Ascendra 2, Edwards SAPIEN XT and NovaFlex are trademarks of Edwards Lifesciences Corporation.
`Edwards Lifesciences, the stylized E logo, Ascendra, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN,
`FloTrac, Fogarty, Magna, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences
`Corporation and are registered in the United States Patent and Trademark Oce.
`
`# # #
`
`Contact Information :
`Media Contact: Sarah Huoh 949-250-5070
`Investor Contact: David K. Erickson 949-250-6826
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`https://www.edwards.com/ns20100302
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`Edwards Lifesciences Corporation, et al. Exhibit 1028, p. 2 of 3
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`Edwards SAPIEN XT Transcatheter Valve and Delivery Systems Receive CE Mark | Edwards Lifesciences
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`Edwards Lifesciences Corporation, et al. Exhibit 1028, p. 3 of 3
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