PARIS, May 17, 2016 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced that 30-day data from its
European post-approval study of the Edwards SAPIEN 3 transcatheter
aortic heart valve demonstrated positive patient outcomes,
including the lowest reported mortality and stroke rates seen in
the SOURCE family of registries.
The new data were presented today at EuroPCR 2016 by
Olaf Wendler, M.D.,
Ph.D., professor of cardiothoracic surgery at King's College
Hospital, London.
The SOURCE 3 Registry, a monitored and adjudicated prospective
registry, is studying use of the low-profile Edwards SAPIEN 3 valve
in a real-world commercial setting, treating patients with severe,
symptomatic aortic stenosis. Patients treated via the transfemoral
access route had a high survival rate of 98.1 percent at 30 days.
Additionally, the study found a low stroke rate of 1.2 percent in
transfemoral patients.
"The high survival and low stroke rates seen in the SOURCE 3
Registry with the SAPIEN 3 valve confirm the positive impact TAVR
provides in the real-world setting," Dr. Wendler said. "These
results give us confidence that the excellent outcomes seen in
early clinical trials using the SAPIEN 3 are reproducible by Heart
Teams in routine practice."
Data from the SOURCE 3 Registry documented the outcomes of 1,947
patients treated at 80 centers in Europe performing transcatheter aortic valve
replacement (TAVR). Patients were enrolled in 10 countries between
July 2014 and October 2015 and will be followed for five years.
This represents the first large, multi-center report of SAPIEN 3
valve patient outcomes in a commercial setting, as well as the
largest dataset of patients who were treated using conscious
sedation with a singular valve platform (1,018 patients). Patients
treated under conscious sedation are awake during the procedure and
do not receive general anesthesia.
The Edwards SAPIEN 3 valve has been available in Europe since 2014. The Edwards SAPIEN family
of valves are the most studied transcatheter heart valves in
history and have been used in the treatment of more than 150,000
patients globally.
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, 2015.
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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