`
`News releases
`
`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.
`
`https://www.edwards.com/ns20111102
`
`1/3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1029, p. 1 of 3
`
`
`
`Edwards Lifesciences Receives FDA Approval for First Catheter-Based Aortic Heart Valve in the U.S. | Edwards Lifesciences
`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. Additional
`company information can be found at www.edwards.com (http://ctt.marketwire.com/?
`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.
`
`# # #
`
`https://www.edwards.com/ns20111102
`
`2/3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1029, p. 2 of 3
`
`
`
`Edwards Lifesciences Receives FDA Approval for First Catheter-Based Aortic Heart Valve in the U.S. | Edwards Lifesciences
`Contact Information :
`Media Contact: Sarah Huoh or Janet Kim 949-250-5070
`Investor Contact: David K. Erickson 949-250-6826
`
`Search Edwards.com
`
`Follow Edwards on:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(https://www.facebook.com/EdwardsGiving)(https://twitter.com/edwardslifesci)(https://www.linkedin.com/company/edwards-(https://www.youtube.com/user/EdwardsGlobal)(http://instagram.com/edwardscareers)
`About us (/aboutus/home)
`lifesciences)
`Careers (/careers/home)
`Investors (http://ir.edwards.com)
`MRI safety (/mri-safety)
`Contact us (/aboutus/contactus)
`Product ordering (/product-ordering)
`Site map (/sitemap)
`Legal terms (/legal/legalterms)
`Privacy policy (/legal/privacypolicy)
`
`(/)
`
`© 2020 Edwards Lifesciences Corporation.
`All rights reserved.
`
`https://www.edwards.com/ns20111102
`
`3/3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1029, p. 3 of 3
`
`
`
`
`
`
`
`