6/21/2017
`
`Edwards Lifesciences Launching Sapien Xt Valve In The U.S. | Edwards Lifesciences
`
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`Edwards Lifesciences Launching Sapien Xt Valve In The U.S.
`
`FDA Approval Includes High-Risk and Inoperable Indications, Transfemoral and Alternative Access
`Systems
`
`IRVINE, CA, June 16, 2014 --Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today
`announced that it has received United States Food and Drug Administration (FDA) approval for its Edwards SAPIEN XT transcatheter aortic heart valve for the
`treatment of high-risk and inoperable patients su摠ering from severe symptomatic aortic stenosis (AS). This next-generation, lower-proᡃle system, which
`includes the 29mm valve size for patients with a large native annulus, will allow for the treatment of more patients.
`
`The Edwards SAPIEN XT valve will be immediately available to patients at leading cardiovascular centers across the nation, along with the NovaFlex+ transfemoral
`delivery system that can be delivered through a low-proᡃle 16-French expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery
`systems.
`
`“There is a substantial and growing body of evidence that the SAPIEN XT valve beneᡃts both high-risk and inoperable patients, and clinicians have documented
`these consistently positive results in both randomized studies and European country registries,” said Martin B. Leon, MD, director, 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. Dr. Leon was the co-principal investigator for the PARTNER II Trial, which was Edwards’ second randomized controlled trial of a transcatheter valve and
`evaluated the SAPIEN XT valve. “The results from the PARTNER II Trial in treating U.S. inoperable patients with the SAPIEN XT valve demonstrated a reduction in
`complications with the TAVR procedure, and improved patient outcomes over earlier trials.”
`
`“Clinicians have demonstrated their conᡃdence in the SAPIEN valves by making them the market-leading transcatheter valves, and this approval provides greater
`options for U.S. patients who can beneᡃt from the substantial enhancements in this proven platform,” said Larry L. Wood, Edwards’ corporate vice president,
`transcatheter heart valves. “The SAPIEN family of valves has been used in the treatment of more than 70,000 patients globally – with the majority of those
`patients treated with SAPIEN XT – and we look forward to Heart Teams across America transforming the lives of even more patients with this advanced
`transcatheter valve.”
`
`The Edwards SAPIEN XT valve has been commercially available in Europe since 2010, and received regulatory and reimbursement approval in Japan in 2013.
`
`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=1117045&id=4237267&type=1&url=http%253a%252f%252fwww.edwards.com%252f).
`
`Important safety information
`
`http://www.edwards.com/ns20140616
`
`1/2
`
`Page 1 of 2
`
`
`
`
`Edwards Lifesciences Launching Sapien Xt Valve In The U.S. | Edwards Lifesciences
`
`News releases
`
`(/)
`
`Therapies
`
`About Us
`
`Specialty Teams
`
`Devices
`
`Education
`
`Patients
`
`Careers
`
`Investors
`
`Select your region:
`
`United States - English
`
`Edwards Lifesciences Launching Sapien Xt Valve In The U.S.
`
`FDA Approval Includes High-Risk and Inoperable Indications, Transfemoral and Alternative Access
`Systems
`
`IRVINE, CA, June 16, 2014 --Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today
`announced that it has received United States Food and Drug Administration (FDA) approval for its Edwards SAPIEN XT transcatheter aortic heart valve for the
`treatment of high-risk and inoperable patients su摠ering from severe symptomatic aortic stenosis (AS). This next-generation, lower-proᡃle system, which
`includes the 29mm valve size for patients with a large native annulus, will allow for the treatment of more patients.
`
`The Edwards SAPIEN XT valve will be immediately available to patients at leading cardiovascular centers across the nation, along with the NovaFlex+ transfemoral
`delivery system that can be delivered through a low-proᡃle 16-French expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery
`systems.
`
`“There is a substantial and growing body of evidence that the SAPIEN XT valve beneᡃts both high-risk and inoperable patients, and clinicians have documented
`these consistently positive results in both randomized studies and European country registries,” said Martin B. Leon, MD, director, 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. Dr. Leon was the co-principal investigator for the PARTNER II Trial, which was Edwards’ second randomized controlled trial of a transcatheter valve and
`evaluated the SAPIEN XT valve. “The results from the PARTNER II Trial in treating U.S. inoperable patients with the SAPIEN XT valve demonstrated a reduction in
`complications with the TAVR procedure, and improved patient outcomes over earlier trials.”
`
`“Clinicians have demonstrated their conᡃdence in the SAPIEN valves by making them the market-leading transcatheter valves, and this approval provides greater
`options for U.S. patients who can beneᡃt from the substantial enhancements in this proven platform,” said Larry L. Wood, Edwards’ corporate vice president,
`transcatheter heart valves. “The SAPIEN family of valves has been used in the treatment of more than 70,000 patients globally – with the majority of those
`patients treated with SAPIEN XT – and we look forward to Heart Teams across America transforming the lives of even more patients with this advanced
`transcatheter valve.”
`
`The Edwards SAPIEN XT valve has been commercially available in Europe since 2010, and received regulatory and reimbursement approval in Japan in 2013.
`
`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=1117045&id=4237267&type=1&url=http%253a%252f%252fwww.edwards.com%252f).
`
`Important safety information
`
`http://www.edwards.com/ns20140616
`
`1/2
`
`Page 1 of 2
`
`
`
`
`6/21/2017
`
`Edwards Lifesciences Launching Sapien Xt Valve In The U.S. | Edwards Lifesciences
`
`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 of Dr. Leon and Mr. Wood and statements regarding the launch status,
`availability and beneᡃts of SAPIEN XT. 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掜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 reᬄect events or circumstances after the date of the statement.
`
`Forward-looking statements involve risks and uncertainties that could cause results to di摠er materially from those expressed or implied by the forward-looking
`statements based on a number of factors, including but not limited to, unanticipated delays in the timing or scale of launch, or unexpected clinical outcomes
`following the U.S. launch, regulatory actions, competitive activity, or quality or manufacturing issues. These factors are detailed in the company's ᡃlings with the
`Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2013.
`
`Edwards, Edwards Lifesciences, the stylized E logo, Ascendra+, Novaᬄex+, eSheath, PARTNER II, SAPIEN and SAPIEN XT are trademarks of Edwards Lifesciences
`Corporation. All other trademarks are the property of their respective owners.
`
`# # #
`
`Contact Information :
`Media Contact: Sarah Huoh 949-250-5070
`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.
`
`Search Edwards.com
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`© 2017 Edwards Lifesciences Corporation.
`All rights reserved.
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`Important safety information
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`http://www.edwards.com/ns20140616
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`2/2
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`Page 2 of 2
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