6/21/2017
`
`Edwards Lifesciences Receives FDA Approval for First CatheterBased Aortic Heart Valve in the U.S. | Edwards Lifesciences
`
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`United States - English
`
`Edwards Lifesciences Receives FDA Approval for First Catheter-Based Aortic Heart Valve in the U.S.
`
`IRVINE, CA, November 02, 2011 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring,
`today announced that it has received approval from the United States Food and Drug Administration (FDA) for the transfemoral delivery of the Edwards SAPIEN
`transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis. This is the rst U.S. commercial approval for a
`transcatheter device enabling aortic valve replacement without the need for open-heart surgery.
`
`Transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN valve enables multi-disciplinary heart teams to replace a patient's diseased aortic valve
`without traditional open-heart surgery and while the heart continues to beat -- avoiding the need for cardiopulmonary bypass.
`
`"This day marks an important milestone for inoperable American patients who have long been awaiting a therapeutic option for the often debilitating symptoms
`associated with severe aortic stenosis," said Michael A. Mussallem, Edwards' chairman and CEO. "We are extremely proud of the dedication of the heart teams
`and the patients involved in the clinical trial for this therapy, who have paved the way for this therapy to help even more people around the world."
`
`In performing the TAVR procedure, the valve is crimped onto the catheter-based transfemoral delivery system, which is inserted into the body through a small cut
`in the leg. Once delivered to the site of the patient's diseased valve, the Edwards SAPIEN valve is expanded with a balloon and immediately functions in place of
`the patient's native valve.
`
`The Edwards SAPIEN valve is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a
`cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected bene t from correction
`of the aortic stenosis.
`
`The safety and e ectiveness of the Edwards SAPIEN transcatheter valve were evaluated in a randomized, controlled pivotal study called The PARTNER Trial. The
`name of the trial signi es the important partnership between cardiac surgeons and interventional cardiologists, who were brought together to collaborate in
`patient evaluation, treatment and follow-up. Additional analyses of data from The PARTNER Trial demonstrated that patients receiving the SAPIEN valve
`experienced substantially better quality of life as compared to the control group patients, and also that TAVR was cost e ective.
`
`As part of this approval, FDA has requested the implementation of two substantial post-approval studies. One study will follow patients already enrolled in The
`PARTNER Trial, and the second study will track new U.S. patients. The company anticipates the second study will be incorporated into a new national patient
`registry.
`
`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 that enable them to save and enhance lives.
`Important safety information
`Additional company information can be found at www.edwards.com (http://ctt.marketwire.com/?
`
`http://www.edwards.com/ns20111102
`
`1/2
`
`Page 1 of 2
`
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`
`
`Edwards Lifesciences Receives FDA Approval for First CatheterBased Aortic Heart 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 Receives FDA Approval for First Catheter-Based Aortic Heart Valve in the U.S.
`
`IRVINE, CA, November 02, 2011 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring,
`today announced that it has received approval from the United States Food and Drug Administration (FDA) for the transfemoral delivery of the Edwards SAPIEN
`transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis. This is the rst U.S. commercial approval for a
`transcatheter device enabling aortic valve replacement without the need for open-heart surgery.
`
`Transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN valve enables multi-disciplinary heart teams to replace a patient's diseased aortic valve
`without traditional open-heart surgery and while the heart continues to beat -- avoiding the need for cardiopulmonary bypass.
`
`"This day marks an important milestone for inoperable American patients who have long been awaiting a therapeutic option for the often debilitating symptoms
`associated with severe aortic stenosis," said Michael A. Mussallem, Edwards' chairman and CEO. "We are extremely proud of the dedication of the heart teams
`and the patients involved in the clinical trial for this therapy, who have paved the way for this therapy to help even more people around the world."
`
`In performing the TAVR procedure, the valve is crimped onto the catheter-based transfemoral delivery system, which is inserted into the body through a small cut
`in the leg. Once delivered to the site of the patient's diseased valve, the Edwards SAPIEN valve is expanded with a balloon and immediately functions in place of
`the patient's native valve.
`
`The Edwards SAPIEN valve is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a
`cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected bene t from correction
`of the aortic stenosis.
`
`The safety and e ectiveness of the Edwards SAPIEN transcatheter valve were evaluated in a randomized, controlled pivotal study called The PARTNER Trial. The
`name of the trial signi es the important partnership between cardiac surgeons and interventional cardiologists, who were brought together to collaborate in
`patient evaluation, treatment and follow-up. Additional analyses of data from The PARTNER Trial demonstrated that patients receiving the SAPIEN valve
`experienced substantially better quality of life as compared to the control group patients, and also that TAVR was cost e ective.
`
`As part of this approval, FDA has requested the implementation of two substantial post-approval studies. One study will follow patients already enrolled in The
`PARTNER Trial, and the second study will track new U.S. patients. The company anticipates the second study will be incorporated into a new national patient
`registry.
`
`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 that enable them to save and enhance lives.
`Important safety information
`Additional company information can be found at www.edwards.com (http://ctt.marketwire.com/?
`
`http://www.edwards.com/ns20111102
`
`1/2
`
`Page 1 of 2
`
`
`
`
`Edwards Lifesciences Receives FDA Approval for First CatheterBased Aortic Heart Valve in the U.S. | Edwards Lifesciences
`6/21/2017
`release=816991&id=950137&type=1&url=http%3a%2f%2fwww.edwards.com%2f).
`
`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 made by Mr. Mussallem and statements regarding the post-approval
`studies for, and the bene ts of, the Edwards SAPIEN valve. 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 re ect events or circumstances after the date
`of the statement.
`
`Forward-looking statements involve risks and uncertainties that could cause the outcomes to di er materially from those expressed or implied by the forward-
`looking statements based on a number of factors including but not limited to unexpected regulatory or reimbursement decisions and longer-term clinical
`experience. 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, 2010.
`
`Edwards, Edwards Lifesciences, the stylized E logo, and Edwards SAPIEN are trademarks of Edwards Lifesciences Corporation.
`
`# # #
`
`Contact Information :
`Media Contact: Sarah Huoh or Janet Kim 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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`Follow Edwards on:
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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/ns20111102
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