6/22/2017
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`Edwards Sapien 3 Transcatheter Heart Valve Receives Expanded Indication In Europe | Edwards Lifesciences
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`Edwards Sapien 3 Transcatheter Heart Valve Receives Expanded Indication In Europe
`
`LONDON, Sept. 19, 2016 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for
`structural heart disease and critical care monitoring, today announced that it has received CE Mark to expand use of the Edwards
`SAPIEN 3 transcatheter heart valve for the treatment of patients su쮅ering from severe, symptomatic aortic stenosis who are at
`intermediate risk for open-heart surgery. 
`
`"This expanded intermediate-risk indication allows for the treatment of even more patients whose only previous option was an open-
`heart surgical procedure," said Prof. Helge Möllmann, Director, Clinic for Internal Medicine (Cardiology) at St. Johannes Hospital,
`Dortmund, Germany. "I am encouraged by the adoption of the position paper of the German Cardiac Society that recommends the use
`of transcatheter aortic valve implantation (TAVI) in intermediate-risk patients based on growing clinical evidence."
`
`For patients with severe aortic stenosis who are at intermediate risk for an open-heart surgical procedure, TAVI using the
`Edwards SAPIEN 3 valve has been shown to demonstrate outcomes that are superior to surgery at one year on a composite primary
`1
`endpoint of mortality, stroke and moderate or severe aortic regurgitation.
`
`The SAPIEN 3 valve builds on Edwards' decades of experience in the development of tissue heart valves, and the proven bene컺ts of the
`Edwards SAPIEN valves. The valve was 컺rst approved in Europe in January 2014 for the treatment of patients with severe, symptomatic
`aortic stenosis who are at high-risk for open heart surgery. The U.S. Food and Drug Administration approved the SAPIEN 3 valve for the
`treatment of intermediate-risk patients in August 2016.
`
`(1)
`
`Thourani V et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a
`propensity score analysis. The Lancet 2016;1-8.
`
`About Edwards Lifesciences
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`Important safety information
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`http://www.edwards.com/ns20160919
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`Edwards Sapien 3 Transcatheter Heart Valve Receives Expanded Indication In Europe | Edwards Lifesciences
`6/22/2017
`Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as
`well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading
`clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more
`information, visit www.Edwards.com (http://www.edwards.com/) and follow us on Twitter @EdwardsLifesci.
`
`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, statements by Prof.
`Möllmann and statements regarding expected product bene컺ts, procedural outcomes and changes to guidelines. 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 di촋cult 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 re쾷ect events or circumstances after the
`date of the statement.
`
`Forward-looking statements involve risks and uncertainties that could cause the roll-out and bene컺ts of the technology to di쮅er
`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 longer term clinical experience, unexpected changes or delays related to product supply, potentials for
`unexpected regulatory, clinical or quality developments, competitive dynamics, litigation and customer acceptance. These factors are
`detailed in the company's 컺lings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year
`ended December 31, 2015.
`
`Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, SAPIEN, SAPIEN 3, are trademarks of Edwards
`Lifesciences Corporation. All other trademarks are the property of their respective owners.
`
`  #
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` # #
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`Contact Information :
`Media: Heather Chambers, 949-250-5070 or
`Investors: David K. Erickson, 949-250-6826
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`Important safety information
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`Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for
`full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
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