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.
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SOURCE Edwards Lifesciences Corporation