6/21/2017
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`Edwards SAPIEN 3 Transcatheter Heart Valve Receives Expanded Indication From FDA | Edwards Lifesciences
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`Edwards SAPIEN 3 Transcatheter Heart Valve Receives Expanded Indication From FDA
`
`IRVINE, Calif., Aug. 18, 2016 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for
`structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration (FDA) approval to expand use
`of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients su埭ering from severe, symptomatic aortic stenosis
`who have been determined by a Heart Team to be at intermediate risk for open-heart surgery. The SAPIEN 3 valve is the 埻rst
`transcatheter aortic valve replacement (TAVR) therapy to obtain this indication in the United States.
`
`"The SAPIEN 3 valve has set a new standard for performance and patient outcomes with aortic valve replacement," said Vinod
`Thourani, M.D., co-director of Emory Heart and Vascular Center's Structural Heart and Valve Center and professor of cardiothoracic
`surgery at Emory University School of Medicine. "The clinical outcomes of 1.1 percent mortality and 1.0 percent disabling stroke at 30
`days in this intermediate-risk population treated with the SAPIEN 3 valve are changing the paradigm of how we treat patients with
`aortic stenosis."
`
`Thourani is the co-principal investigator of the SAPIEN 3 valve study. 
`
`"The intermediate-risk approval of the SAPIEN 3 valve is a major milestone, since it provides a less-invasive therapy that has
`demonstrated better outcomes for aortic valve patients, and is supported by the largest and rigorous comparative body of evidence for
`the treatment of aortic stenosis," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves.
`
`The SAPIEN 3 valve intermediate-risk approval was based on data from a cohort of the PARTNER II Trial, which studied 2,005
`intermediate-risk patients at 51 sites in the United States and Canada. The study demonstrated that patients treated with the SAPIEN
`3 valve experienced clinically signi埻cant improvements for the composite primary endpoint of mortality, stroke and moderate or severe
`aortic regurgitation at one year as compared to those treated with surgery.  The data were presented in April at the American College
`of Cardiology's 65  Annual Scienti埻c Session and simultaneously published in The Lancet.
`th
`
`The expanded intermediate-risk indication granted by the FDA enables Heart Teams to treat patients with the SAPIEN 3 valve who
`they determine to have a predicted risk of surgical mortality of greater than or equal to 3 percent at 30 days, based on the Society of
`Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator.  
`Important safety information
`
`http://www.edwards.com/ns20160818
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`Edwards SAPIEN 3 Transcatheter Heart Valve Receives Expanded Indication From FDA | Edwards Lifesciences
`6/21/2017
`The SAPIEN 3 valve builds on Edwards' decades of experience in the development of tissue heart valves, and the proven bene埻ts of the
`Edwards SAPIEN valves. The SAPIEN 3 valve was approved by the FDA in June 2015 for the treatment of patients with severe,
`symptomatic aortic stenosis who are at high-risk for open heart surgery.  
`
`About Edwards Lifesciences
`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 Dr.
`Thourani and Mr. Wood and statements regarding expected product bene埻ts 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 di埒cult 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 re埾ect events or circumstances after the date of the
`statement.
`
`Forward-looking statements involve risks and uncertainties that could cause the roll-out and bene埻ts of the technology to di埭er
`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, competitive dynamics, litigation and customer acceptance. These factors are
`detailed in the company's 埻lings 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, PARTNER and PARTNER II
`are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
`
`  #
`
` # #
`
`Contact Information :
`Media, Heather Chambers, 949-250-5070, or
`Investors, David K. Erickson, 949-250-6826, both of Edwards Lifesciences Corporation
`
`Important safety information
`
`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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