6/21/2017
`
`Edwards Lifesciences Announces First Human Implants With 18 French Transcatheter Valve System | Edwards Lifesciences
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`Edwards Lifesciences Announces First Human Implants With 18 French Transcatheter Valve System
`
`IRVINE, CA, May 14, 2009 -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced the successful
`completion of the ៍rst human implants of its next-generation transcatheter aortic heart valve used with its new 18 French delivery system. Edwards expects these
`cases, performed in Canada, to be reviewed next week at EuroPCR 2009.
`
`The 18 French system features the Edwards SAPIEN XT valve paired with its new, smaller NovaFlex transfemoral delivery system. The valve has a cobalt chromium
`alloy balloon-expandable frame, which allows for a signi៍cant reduction in its pro៍le, and bovine pericardial tissue leaퟍets processed in the same stringently
`controlled manner as Edwards' market-leading surgical heart valves. The NovaFlex delivery system leverages the ease-of-use features of the Edwards RetroFlex
`line of delivery systems.
`
`"The clinical success of the Edwards SAPIEN valve has allowed us to treat patients who previously had no good treatment options. The new Edwards SAPIEN XT
`valve, with its improved design and revolutionary lower pro៍le delivery system, will allow us to treat aortic stenosis patients even more reliably and safely," said
`John Webb, M.D., who performed the ៍rst successful human implants of the new transcatheter system. Webb is director of the cath lab and cardiac intervention at
`St. Paul's Hospital in Vancouver, British Columbia, and a consultant to Edwards Lifesciences.
`
`While the Edwards SAPIEN XT valve is being evaluated in the PREVAIL EU trial for CE Mark approval, the commercial rollout of Edwards' RetroFlex 3 delivery
`system to be used with the Edwards SAPIEN valve is underway in Europe. The RetroFlex 3 delivery system is designed to optimize physician control of valve
`navigation and facilitate crossing of the patient's native calci៍ed aortic valve.
`
`"We are dedicated to leading the rapid advancement of transcatheter heart valve technology," said Larry L. Wood, Edwards' corporate vice president,
`transcatheter valve replacement. "The commercial launch of the RetroFlex 3 delivery system and the enhancements incorporated into the NovaFlex delivery
`system with the Edwards SAPIEN XT valve are designed to make transcatheter valve therapy accessible to even more patients."
`
`Representatives from Edwards will be at Booth #F02 at EuroPCR 2009, May 19-22 in Barcelona, Spain. Simulators in the EuroPCR 2009 Training Village will
`provide the opportunity for a virtual procedural experience with the RetroFlex 3 transfemoral and Ascendra transapical delivery systems.
`
`The Edwards SAPIEN valve is approved for commercial sale in Europe. In the United States, it is being studied as part of a randomized, pivotal clinical trial.
`
`About Edwards Lifesciences
`
`Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than ៍ve decades of experience in partnering
`with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart
`valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-
`Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at
`Important safety information
`http://www.edwards.com/ (http://www.edwards.com/).
`
`http://www.edwards.com/ns20090514
`
`1/2
`
`Page 1 of 2
`
`
`
`
`Edwards Lifesciences Announces First Human Implants With 18 French Transcatheter Valve System | Edwards Lifesciences
`
`News releases
`
`(/)
`
`Therapies
`
`About Us
`
`Specialty Teams
`
`Devices
`
`Education
`
`Patients
`
`Careers
`
`Investors
`
`Select your region:
`
`United States - English
`
`Edwards Lifesciences Announces First Human Implants With 18 French Transcatheter Valve System
`
`IRVINE, CA, May 14, 2009 -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced the successful
`completion of the ៍rst human implants of its next-generation transcatheter aortic heart valve used with its new 18 French delivery system. Edwards expects these
`cases, performed in Canada, to be reviewed next week at EuroPCR 2009.
`
`The 18 French system features the Edwards SAPIEN XT valve paired with its new, smaller NovaFlex transfemoral delivery system. The valve has a cobalt chromium
`alloy balloon-expandable frame, which allows for a signi៍cant reduction in its pro៍le, and bovine pericardial tissue leaퟍets processed in the same stringently
`controlled manner as Edwards' market-leading surgical heart valves. The NovaFlex delivery system leverages the ease-of-use features of the Edwards RetroFlex
`line of delivery systems.
`
`"The clinical success of the Edwards SAPIEN valve has allowed us to treat patients who previously had no good treatment options. The new Edwards SAPIEN XT
`valve, with its improved design and revolutionary lower pro៍le delivery system, will allow us to treat aortic stenosis patients even more reliably and safely," said
`John Webb, M.D., who performed the ៍rst successful human implants of the new transcatheter system. Webb is director of the cath lab and cardiac intervention at
`St. Paul's Hospital in Vancouver, British Columbia, and a consultant to Edwards Lifesciences.
`
`While the Edwards SAPIEN XT valve is being evaluated in the PREVAIL EU trial for CE Mark approval, the commercial rollout of Edwards' RetroFlex 3 delivery
`system to be used with the Edwards SAPIEN valve is underway in Europe. The RetroFlex 3 delivery system is designed to optimize physician control of valve
`navigation and facilitate crossing of the patient's native calci៍ed aortic valve.
`
`"We are dedicated to leading the rapid advancement of transcatheter heart valve technology," said Larry L. Wood, Edwards' corporate vice president,
`transcatheter valve replacement. "The commercial launch of the RetroFlex 3 delivery system and the enhancements incorporated into the NovaFlex delivery
`system with the Edwards SAPIEN XT valve are designed to make transcatheter valve therapy accessible to even more patients."
`
`Representatives from Edwards will be at Booth #F02 at EuroPCR 2009, May 19-22 in Barcelona, Spain. Simulators in the EuroPCR 2009 Training Village will
`provide the opportunity for a virtual procedural experience with the RetroFlex 3 transfemoral and Ascendra transapical delivery systems.
`
`The Edwards SAPIEN valve is approved for commercial sale in Europe. In the United States, it is being studied as part of a randomized, pivotal clinical trial.
`
`About Edwards Lifesciences
`
`Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than ៍ve decades of experience in partnering
`with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart
`valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-
`Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at
`Important safety information
`http://www.edwards.com/ (http://www.edwards.com/).
`
`http://www.edwards.com/ns20090514
`
`1/2
`
`Page 1 of 2
`
`
`
`
`6/21/2017
`
`Edwards Lifesciences Announces First Human Implants With 18 French Transcatheter Valve System | 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, the timing and progress of clinical studies relating to the company's transcatheter
`valve technologies and the market opportunity 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⠀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 reퟍect events or
`circumstances after the date of the statement.
`
`Forward-looking statements involve risks and uncertainties that could cause actual results or experience to di韉er materially from that expressed or implied by the
`forward-looking statements. Factors that could cause actual results or experience to di韉er materially from that expressed or implied by the forward-looking
`statements 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, 2008.
`
`Edwards, Edwards SAPIEN XT, NovaFlex and RetroFlex 3 are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Ascendra,
`Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN , FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences
`Corporation and are registered in the United States Patent and Trademark O⠀ce.
`
`# # #
`
`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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`About us (/aboutus/home)
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`© 2017 Edwards Lifesciences Corporation.
`All rights reserved.
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`http://www.edwards.com/ns20090514
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