Edwards Receives European Approval for Advanced SAPIEN 3 Valve | Edwards Lifesciences
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`News releases
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`Edwards Receives European Approval for Advanced SAPIEN 3 Valve
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`IRVINE, CA, January 27, 2014 -- 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 in Europe and is
`initiating the launch of its most advanced transcatheter aortic valve, the Edwards SAPIEN 3 valve.
`
`The SAPIEN 3 valve builds upon Edwards' decades of experience in the development of tissue heart valves, and
`the proven benets of the Edwards SAPIEN valves. The new valve has an outer skirt -- a cu of fabric
`surrounding the valve frame -- providing a seal to address paravalvular leak. The eectiveness of this solution
`is supported by the limited clinical experience(1, 2), as detailed in two rst-in-human feasibility studies, which
`demonstrated that signicant paravalvular leak was eliminated during transcatheter aortic valve implantation
`(TAVI).
`
`The SAPIEN 3 valve is the only commercial transcatheter heart valve that can be delivered through a low-prole
`14 French expandable sheath (eSheath), which has shown through early clinical experience a low rate of
`complications(1, 2). The valve can be implanted through multiple approaches: transfemoral, transapical or
`transaortic. Once implanted, the discreet valve anchors in the aortic annulus.
`
`"European physicians have been eagerly awaiting the launch of the Edwards SAPIEN 3 valve, and we are very
`excited to make it available today. It has a unique design intended to provide a simpler procedure, along with
`fewer post-procedural complications and a faster recovery for patients," said Larry L. Wood, Edwards' corporate
`vice president, transcatheter heart valves. "Based on our clinical leadership in transcatheter heart valves, we
`believe the SAPIEN 3 valve's characteristics and procedural renements have the potential to transform TAVI for
`both physicians and patients."
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`https://www.edwards.com/ns20140127
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`Edwards Lifesciences Corporation, et al. Exhibit 1014, p. 1 of 3
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`Edwards Receives European Approval for Advanced SAPIEN 3 Valve | Edwards Lifesciences
`In the United States, the Edwards SAPIEN 3 valve is an investigational device being studied in the PARTNER II
`Trial and is not yet available for sale in the country.
`
`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 www.edwards.com (http://ctt.marketwire.com/?
`release=1084659&id=3826816&type=1&url=http%3a%2f%2fwww.edwards.com%2f).
`
`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, Mr. Wood's statements and statements regarding the expected launch of the Edwards
`SAPIEN 3 valve, design features and expected product benets and procedural outcomes. 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 the roll-out and benets of the
`technology to dier materially from those expressed or implied by the forward-looking statements based on a
`number of factors including but not limited to unexpected outcomes after more expanded clinical experience,
`unexpected changes or delays related to product supply, potentials for unexpected regulatory or quality
`developments, and customer acceptance. These factors 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, 2012.
`
`Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, SAPIEN XT, SAPIEN 3, eSheath, PARTNER
`and PARTNER II are trademarks of Edwards Lifesciences Corporation.
`
`(1) Binder RK, Rodés-Cabau J, Wood DA, et al. Transcatheter Aortic Valve Replacement With the SAPIEN 3: A
`New Balloon-Expandable Transcatheter Heart Valve. J Am Coll Cardiol Intv. 2013;6(3):293-300.
`doi:10.1016/j.jcin.2012.09.019.
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`(2) Dvir D, Barbanti M, De Larochelliere R, et al. TCT-787 Preliminary Clinical Experience using the SAPIEN 3
`device. J Am Coll Cardiol. 2013;62(18_S1):B239. doi:10.1016/j.jacc.2013.08.1539.
`
`# # #
`
`Contact Information :
`Media Contact: Sarah Huoh 949-250-5070
`Investor Contact: David K. Erickson 949-250-6826
`
`Search Edwards.com
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`https://www.edwards.com/ns20140127
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`Edwards Lifesciences Corporation, et al. Exhibit 1014, p. 2 of 3
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`Edwards Receives European Approval for Advanced SAPIEN 3 Valve | Edwards Lifesciences
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`https://www.edwards.com/ns20140127
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`Edwards Lifesciences Corporation, et al. Exhibit 1014, p. 3 of 3
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