6/21/2017
`
`Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences
`
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`United States - English
`
`Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
`
`IRVINE, Calif., Sept. 5, 2007 -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced that it has
`received CE Mark approval for European commercial sales of its Edwards SAPIEN transcatheter aortic heart valve technology with the RetroFlex transfemoral
`delivery system.
`
`The Edwards SAPIEN transcatheter heart valve is implanted via a minimally-invasive procedure, without requiring open-heart surgery. It is the 韢rst transcatheter
`bovine pericardial valve incorporating technological advancements and design elements that allow for greater ease of implantation by physicians. The valve is
`designed to treat patients with severe aortic heart valve stenosis (a narrowing of the valve that restricts blood 韤ow), who are considered to be high-risk or non-
`operable for conventional open-heart valve replacement surgery.
`
`"This is a landmark achievement for this transformational technology, which holds promise for the large number of high-risk patients su韕ering from severe
`aortic stenosis," said Michael A. Mussallem, Edwards Lifesciences' chairman and CEO. "As the global leader in heart valve therapy, we are committed to working
`closely with our European clinical partners on this transcatheter technology, in order to provide optimal clinical outcomes for the many high-risk patients in need
`of aortic valve replacements, who might otherwise have limited or no treatment options."
`
`"In this pioneering procedure, the skill sets of the surgeon and the interventional cardiologist complement each other to provide for better patient care," said
`Martin B. Leon, MD, Professor of Medicine and Associate Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center and the
`principal investigator for the Edwards PARTNER pivotal trial in the United States. "Several years of clinical experience have demonstrated that optimal outcomes
`can be achieved with a collaborative, multi-disciplinary team."
`
`The Edwards SAPIEN transcatheter heart valve integrates balloon-expandable stent technology that leverages Edwards' proprietary bovine pericardial tissue and
`30 years of design and manufacturing expertise. With the RetroFlex transfemoral delivery system, the Edwards SAPIEN valve is compressed onto the balloon to the
`approximate diameter of a pencil and threaded through the patient's circulatory system from the leg and expanded securely into place directly over the diseased
`aortic valve.
`
`Edwards has achieved almost 500 implants of the transcatheter heart valve through a series of extensive clinical trials and feasibility studies in Europe, the U.S.
`and Canada. The company is proceeding on schedule with European launch preparations, including establishing training centers, selecting proctors for commercial
`site training, and progressing country-speci韢c reimbursement plans, and will begin selling the device, as planned, in the fourth quarter of 2007.
`
`The company has also submitted for CE Mark approval the Edwards SAPIEN transcatheter heart valve with the Ascendra transapical delivery system -- in which
`the valve is inserted between the ribs -- providing interventional cardiologists and surgeons with a second valve delivery option. The Ascendra transapical delivery
`system is expected to receive CE Mark by the end of the year.
`
`About Edwards Lifesciences
`Important safety information
`
`http://www.edwards.com/ns20070905
`
`1/2
`
`Page 1 of 2
`
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`
`
`Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences
`
`News releases
`
`(/)
`
`Therapies
`
`About Us
`
`Specialty Teams
`
`Devices
`
`Education
`
`Patients
`
`Careers
`
`Investors
`
`United States - English
`
`Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
`
`IRVINE, Calif., Sept. 5, 2007 -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced that it has
`received CE Mark approval for European commercial sales of its Edwards SAPIEN transcatheter aortic heart valve technology with the RetroFlex transfemoral
`delivery system.
`
`The Edwards SAPIEN transcatheter heart valve is implanted via a minimally-invasive procedure, without requiring open-heart surgery. It is the 韢rst transcatheter
`bovine pericardial valve incorporating technological advancements and design elements that allow for greater ease of implantation by physicians. The valve is
`designed to treat patients with severe aortic heart valve stenosis (a narrowing of the valve that restricts blood 韤ow), who are considered to be high-risk or non-
`operable for conventional open-heart valve replacement surgery.
`
`"This is a landmark achievement for this transformational technology, which holds promise for the large number of high-risk patients su韕ering from severe
`aortic stenosis," said Michael A. Mussallem, Edwards Lifesciences' chairman and CEO. "As the global leader in heart valve therapy, we are committed to working
`closely with our European clinical partners on this transcatheter technology, in order to provide optimal clinical outcomes for the many high-risk patients in need
`of aortic valve replacements, who might otherwise have limited or no treatment options."
`
`"In this pioneering procedure, the skill sets of the surgeon and the interventional cardiologist complement each other to provide for better patient care," said
`Martin B. Leon, MD, Professor of Medicine and Associate Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center and the
`principal investigator for the Edwards PARTNER pivotal trial in the United States. "Several years of clinical experience have demonstrated that optimal outcomes
`can be achieved with a collaborative, multi-disciplinary team."
`
`The Edwards SAPIEN transcatheter heart valve integrates balloon-expandable stent technology that leverages Edwards' proprietary bovine pericardial tissue and
`30 years of design and manufacturing expertise. With the RetroFlex transfemoral delivery system, the Edwards SAPIEN valve is compressed onto the balloon to the
`approximate diameter of a pencil and threaded through the patient's circulatory system from the leg and expanded securely into place directly over the diseased
`aortic valve.
`
`Edwards has achieved almost 500 implants of the transcatheter heart valve through a series of extensive clinical trials and feasibility studies in Europe, the U.S.
`and Canada. The company is proceeding on schedule with European launch preparations, including establishing training centers, selecting proctors for commercial
`site training, and progressing country-speci韢c reimbursement plans, and will begin selling the device, as planned, in the fourth quarter of 2007.
`
`The company has also submitted for CE Mark approval the Edwards SAPIEN transcatheter heart valve with the Ascendra transapical delivery system -- in which
`the valve is inserted between the ribs -- providing interventional cardiologists and surgeons with a second valve delivery option. The Ascendra transapical delivery
`system is expected to receive CE Mark by the end of the year.
`
`About Edwards Lifesciences
`Important safety information
`
`http://www.edwards.com/ns20070905
`
`1/2
`
`Page 1 of 2
`
`
`
`
`6/21/2017
`
`Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences
`
`Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute
`hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on speci韢c cardiovascular disease states including heart valve disease, peripheral
`vascular disease and critical care technologies. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards,
`Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://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 timely regulatory approval of the Edwards SAPIEN transcatheter aortic heart valve;
`the timing and progress of clinical studies relating to the company's transcatheter valve technologies and the market opportunity for these products; the expected
`European launch of the Edwards SAPIEN valve and the anticipation of beginning sales in fourth quarter of 2007; and the market for transcatheter technologies.
`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韭cult to predict.
`
`Forward-looking statements involve risks and uncertainties that could cause actual results or experience to di韕er materially from that expressed or implied by the
`forward-looking statements. Factors that could cause actual results or experience to di韕er materially from that expressed or implied by the forward-looking
`statements are detailed in the company's 韢lings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended
`December 31, 2006.
`
`Ascendra, Edwards, Edwards SAPIEN and RetroFlex are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-
`Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT, PERIMOUNT Magna, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are
`registered in the United States Patent and Trademark O韭ce. LifeStent is a trademark of Edwards Lifesciences AG and registered in the United States Patent and
`Trademark O韭ce.
`
`Contact Information :
`Media, Sarah Huoh, +1-949-250-5070, or Investors, David K. Erickson, +1-949-250-6826, 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.
`
`Search Edwards.com
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`Follow Edwards on:
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`(https://www.facebook.com/EdwardsGiving)(https://twitter.com/edwardslifesci)(https://www.linkedin.com/company/edwards-(https://www.youtube.com/user/EdwardsGlobal)
`About us (/aboutus/home)
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`© 2017 Edwards Lifesciences Corporation.
`All rights reserved.
`
`Important safety information
`
`http://www.edwards.com/ns20070905
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