6/22/2017
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`Edwards Receives FDA Approval For SAPIEN 3 Transcatheter Heart Valve | Edwards Lifesciences
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`Edwards Receives FDA Approval For SAPIEN 3 Transcatheter Heart Valve
`
`Approved For High-Risk Indication and All Valve Sizes
`
`IRVINE, Calif., June 17, 2015 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and
`hemodynamic monitoring, today announced U.S. Food and Drug Administration (FDA) approval of its most advanced transcatheter
`aortic heart valve – the Edwards SAPIEN 3 valve with the Commander Delivery System – for the treatment of high-risk patients
`suering from severe, symptomatic aortic stenosis.       
`
`"The SAPIEN 3 valve sets a new standard for transcatheter heart valve performance and patient outcomes," said Martin B. Leon, MD,
`director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center and professor
`of medicine at the Columbia University College of Physicians and Surgeons. "We have seen some of the best results to date from the
`PARTNER II Trial in treating high-risk patients with the SAPIEN 3 valve. The PARTNER II study concluded that this new valve reduced
`several complications associated with the TAVR procedure such as paravalvular leakage and stroke, and represented a meaningful
`improvement over data from prior studies with earlier-generation devices," Leon said.
`
`Dr. Leon was the co-principal investigator for the PARTNER II Trial. SAPIEN 3 approval was based on a cohort of the PARTNER II Trial,
`which enrolled 583 high-risk patients at 29 U.S. sites.
`
`The SAPIEN 3 valve builds on Edwards' decades of experience in the development of tissue heart valves, and the proven bene&ts of the
`Edwards SAPIEN valves. The new valve, available in 20mm, 23mm, 26mm and 29mm sizes, has an outer skirt – a cu of fabric
`surrounding the valve frame – providing a seal to address paravalvular leak. 
`
`"U.S. physicians have been eagerly awaiting the launch of the Edwards SAPIEN 3 valve since it became available in Europe last year,
`and we appreciate the FDA's timely and thoughtful review in making this device available to American patients," said Larry L. Wood,
`Edwards' corporate vice president, transcatheter heart valves. "Based on extensive research and high quality clinical data, we believe
`the SAPIEN 3 valve has the potential to transform patient care in the U.S."  
`Important safety information
`
`http://www.edwards.com/ns20150617
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`Edwards Receives FDA Approval For SAPIEN 3 Transcatheter Heart Valve | Edwards Lifesciences
`6/22/2017
`Given the earlier-than-anticipated FDA approval of SAPIEN 3, the company is ramping up supply and expects the launch to be largely
`completed by the end of the year.
`
`The SAPIEN 3 valve has been commercially available in Europe since January 2014. The SAPIEN family of valves has been used in the
`treatment of more than 100,000 patients globally.
`
`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://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, statements by Dr. Leon
`and Mr. Wood and statements regarding the expected launch of the Edwards SAPIEN 3 valve, design features and expected product
`bene&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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 reect events or circumstances after the date of the statement.
`
`Forward-looking statements involve risks and uncertainties that could cause the roll-out and bene&ts 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, competitive dynamics, global economic conditions 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, 2014.
`
`Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, SAPIEN 3, eSheath, and PARTNER II are trademarks of Edwards
`Lifesciences Corporation. 
`
`  #
`
` # #
`
`Contact Information :
`Media Contact: Heather Chambers, 949-250-2753;
`Investor Contact: David K. Erickson, 949-250-6826
`
`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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`Edwards Receives FDA Approval For SAPIEN 3 Transcatheter Heart Valve | Edwards Lifesciences
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`© 2017 Edwards Lifesciences Corporation.
`All rights reserved.
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