CHICAGO, April 3, 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 new data on patients
at intermediate risk for open-heart surgery demonstrated that
transcatheter aortic valve replacement (TAVR) with the SAPIEN 3
valve was superior to surgery at one year on a composite primary
endpoint of mortality, stroke and moderate or severe aortic
regurgitation. In addition, the SAPIEN 3 valve demonstrated
clinical superiority at one year on individual assessments of
all-cause mortality and of stroke. The results of the study
of 1,078 enrolled patients with severe, symptomatic aortic stenosis
were presented as part of the late-breaking clinical trials at the
American College of Cardiology's 65th Annual Scientific
Session (ACC.16) in Chicago, and
simultaneously published online in The Lancet.
"Results from the PARTNER II Trial presented at ACC should
establish the SAPIEN 3 valve as the new benchmark for the treatment
of intermediate-risk patients with severe, symptomatic aortic
stenosis," said Vinod Thourani,
M.D., co-director, Structural Heart and Valve Center of the Emory
Heart and Vascular Center, chief of cardiothoracic surgery at Emory
Hospital Midtown and professor of surgery, Division of
Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine. Thourani
is the co-principal investigator of the SAPIEN 3 study. "The
size and rigor of this 3,000-patient PARTNER II Trial provide
powerful evidence in favor of this therapy for the treatment of
patients with aortic stenosis."
From February 2014 through
September 2014, 1,078
intermediate-risk patients were enrolled in the SAPIEN 3 study at
51 sites in the United States and
Canada. One-year SAPIEN 3 outcomes were compared with
one-year surgical outcomes from 944 intermediate-risk patients
treated with surgery in the PARTNER II randomized trial.
Important clinical measures from the study are presented in the
table below.
Clinical Outcomes from The PARTNER II Intermediate-Risk Trial
with the SAPIEN 3 Valve (As-Treated)*:
|
30
Days
|
1
Year
|
Clinical
Outcomes (As-Treated)
|
SAPIEN 3
(N = 1,077)
|
Surgery
(N = 944)**
|
SAPIEN
3
(N = 1,077)
|
Surgery
(N = 944)**
|
Death:
|
|
|
|
|
Death: all-cause -
%
|
1.1
|
4.0
|
7.4
|
13.0
|
Death: cardiovascular
- %
|
0.9
|
3.1
|
4.5
|
8.1
|
|
|
|
|
|
Neurological
Events:
|
|
|
|
|
Stroke: all -
%
|
2.7
|
6.1
|
4.6
|
8.2
|
Stroke: disabling -
%
|
1.0
|
4.4
|
2.3
|
5.9
|
|
|
|
|
|
All-cause Death
and Disabling Stroke
|
2.0
|
8.0
|
8.4
|
16.6
|
*In a pre-specified propensity-score analysis developed in
partnership with the FDA, outcomes from the SAPIEN 3 TAVR patient
cohort were compared with outcomes from the surgical arm of the
PARTNER II A Trial.
** The full PARTNER II Trial two-year
results of intermediate-risk patients were presented at ACC on
April 2, and published online in
The New England Journal of Medicine.
Moderate or severe aortic regurgitation was 0.6 percent for
surgery which was superior to the 1.5 percent for TAVR at one
year.
The SAPIEN 3 valve was approved by the U.S. Food and Drug
Administration in June 2015 for the
treatment of high-risk patients with severe, symptomatic aortic
stenosis; the valve is not approved for the treatment of
intermediate-risk patients in the U.S. The company has been
planning for a U.S. approval late this year. More information
on financial guidance and timing will be available during the
company's earnings call April 26. The SAPIEN family of valves
has been used in the treatment of more than 150,000 patients
globally.
Investor Event
Edwards is conducting an investor event Sunday, April 3, 2016, at 6:30 p.m. Eastern/5:30
p.m. Central. This event will be accessible via live webcast
at http://ir.edwards.com and available for replay on the "Investor
Relations" section of the Edwards web site.
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. Thourani's
statements and statements regarding expected timing for regulatory
approvals and impact on financial results, as well as statements
regarding expected product features, risks and benefits.
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 delays or changes
in regulatory approval decisions; unanticipated delays of the new
product indication launch or in outcomes following 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, 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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