SAN FRANCISCO, Oct. 15, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
that high-risk patients who received the advanced Edwards SAPIEN 3
transcatheter aortic valve via transfemoral delivery had a one-year
survival rate of 89.3 percent, as well as low rates of stroke and
paravalvular leak. The independently adjudicated data from
The PARTNER II S3 Trial, which studied 583 high-risk and inoperable
patients in the United States,
were presented by Howard C.
Herrmann, M.D., the John Winthrop Bryfogle Professor of
Cardiovascular Diseases, and Director of Penn Medicine's
Interventional Cardiology Program in the Perelman School of
Medicine at the University of
Pennsylvania, during the late-breaking clinical trials
session at the 27th Transcatheter Cardiovascular Therapeutics
(TCT), the annual scientific symposium of the Cardiovascular
Research Foundation.
Among the one-year outcomes reported in this large, rigorous
U.S. FDA study, SAPIEN 3 transcatheter aortic valve
replacement (TAVR) was associated with a very low overall disabling
stroke rate of 2.4 percent, which is lower than this patient
population's general risk of stroke.1,2
There were zero patients with severe paravalvular leak and only
2.7 percent with moderate paravalvular leak. Furthermore, for
patients with mild or less paravalvular leak, there was no
association with increased mortality. There was no evidence of
clinical valve thrombosis or structural valve deterioration in
these patients.
"These excellent results with the SAPIEN 3 valve support
the use of TAVR as the preferred therapy for patients at high or
greater risk for surgical aortic valve replacement," said Herrmann.
"The combination of new design features of the SAPIEN 3 valve,
procedural improvements, operator experience and improved patient
selection have all contributed to strikingly low rates of one-year
mortality, as well as other important adverse events, including
stroke, in high-risk and inoperable patients with severe aortic
stenosis."
The SAPIEN 3 study is a single-arm, non-randomized cohort
of The PARTNER II Trial. The one-year analysis documented
outcomes of the first 583 patients, whose average age was over 80,
treated with the SAPIEN 3 valve at 29 centers nationwide and
concluded January 2014. Access approaches included
transfemoral (n=491) and transapical/transaortic (n=92), both
high-risk and inoperable, as determined by the Heart
Team.
The SAPIEN 3 valve was approved in Europe in January
2014 and in the U.S. in June
2015 for the treatment of high-risk patients with severe
aortic stenosis.
Clinical Outcomes at 1 Year from The PARTNER II
High-Risk/Inoperable Trial with the SAPIEN 3 Valve
(As-Treated):
Clinical
Outcomes
|
30
Days
|
1
Year
|
All-cause mortality -
%
|
2.2
|
14.4
|
Stroke: disabling -
%
|
0.9
|
2.4
|
All percents cited in the press release are Kaplan-Meier
estimates.
Herrmann has received speaking honoraria from
Edwards Lifesciences.
1 Mozaffarian D et al. Heart disease and
stroke statistics - 2015 Update: A report from the American Heart
Association. Circulation 2015;e29-e322.
2 Friberg L et al. Evaluation of risk
stratification schemes for ischemia stroke and bleeding in 182678
patients with atrial fibrillation: the Swedish Atrial Fibrillation
cohort study. European Heart Journal 2012;33, 1500-1510.
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, enabling them to save and enhance
lives. Additional company information can be found at
www.edwards.com.
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 by Dr.
Herrmann and statements regarding patient follow-up, design
features and expected product benefits and procedural outcomes of
TAVR with the Edwards SAPIEN 3 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 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 actual 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 more expanded clinical experience and longer term follow-up,
unexpected product supply, regulatory or quality developments, and
changes to trends in customer experience or patient follow-up.
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, 2014. These filings,
along with important safety information about our products, may be
found at www.edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER II, SAPIEN and
SAPIEN 3 are trademarks of Edwards Lifesciences Corporation.
All other trademarks are the property of their respective
owners.
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