Real-World Evidence With Edwards SAPIEN 3 Transcatheter Valve Confirms Beneficial Patient Outcomes From Clinical Trials

PARIS, May 16, 2017 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced that new 1-year data from a large European post-approval study of the Edwards SAPIEN 3 transcatheter heart valve demonstrated positive patient outcomes including high survival rates and low rates of stroke and paravalvular leak.

The 1,946-patient data were presented today at EuroPCR 2017 by Olaf Wendler, M.D., Ph.D., professor of cardiac surgery at King's College Hospital, London, and will be published in European Heart Journal.

"These 'real-world' outcomes with the SAPIEN 3 valve in a commercial setting continue to support the compelling clinical case for transcatheter aortic valve replacement (TAVR), and, once again, demonstrate consistency in clinical practice between pivotal studies and global commercial experience," Wendler said. 

The SOURCE 3 Registry, a monitored and adjudicated prospective registry, is studying use of the market-leading Edwards SAPIEN 3 valve in a real-world commercial setting, treating patients with severe, symptomatic aortic stenosis. At 1 year, patients treated via the transfemoral access route had a high survival rate (88.2 percent) and a very low disabling stroke rate (1.1 percent). Additionally, these patients experienced a low 2.7 percent rate of moderate paravalvular leak, and no severe paravalvular leak. 

The majority of patients in the SOURCE 3 Registry were treated via transfemoral access and more than half were treated under conscious sedation. Patients were enrolled at 80 centers across 10 countries between July 2014 and October 2015. They will be followed for five years.

The Edwards SAPIEN 3 valve has been available in Europe since 2014. The SAPIEN 3 valve builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves.

Dr. Wendler is a consultant to Edwards Lifesciences.

About Edwards Lifesciences

Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.Edwards.com and follow us on Twitter @EdwardsLifesci.

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, Dr. Wendler's statements and statements regarding expected future product benefits and results. 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 difficult 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 reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unexpected outcomes after longer term clinical experience with the product; or unanticipated quality, manufacturing or regulatory delays or issues. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, SAPIEN, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

SOURCE Edwards Lifesciences Corporation

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