SAN DIEGO, March 15, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
that 30-day outcomes for high- and intermediate-risk patients
treated with the SAPIEN 3 transcatheter aortic valve demonstrated
the lowest all-cause mortality rates of any of the PARTNER studies,
as well as excellent clinical outcomes on the other components of
the primary endpoint measures of stroke and paravalvular
regurgitation. This first report of SAPIEN 3 data in
the United States, and first
report on intermediate risk transcatheter aortic valve replacement
(TAVR) patients, was presented as part of the late-breaking
clinical trials at the American College of Cardiology's (ACC)
64th Annual Scientific Session in San Diego.
"These results of more than 1,600 patients treated with the
SAPIEN 3 valve demonstrate the most significant progress in the
development of TAVR and the SAPIEN family of valves since the first
PARTNER study was initiated in 2007," said Susheel Kodali, M.D., director, Heart Valve
Program, at NewYork-Presbyterian/Columbia
University Medical Center and assistant professor of
medicine at the Columbia University
College of Physicians and Surgeons. Kodali is the
co-principal investigator for the SAPIEN 3 studies. "With
average ages in the 80s, the high-risk and intermediate-risk
patients in the study had strikingly low mortality rates of 2.2 and
1.1, respectively, despite predicted 30-day mortality that was much
higher. Additionally, the rates of significant paravalvular
leaks were low in both cohorts – 3.0 for high-risk and 4.2 for
intermediate – which represented meaningful improvements over prior
studies with earlier generation devices."
The SAPIEN 3 high-risk cohort enrolled 583 patients at 29 U.S.
sites; the intermediate risk cohort enrolled 1,076 patients at 51
U.S. sites. Both studies were single-arm, non-randomized
cohorts of the PARTNER II Trial. Important clinical measures
from the studies are presented in the table below.
The SAPIEN 3 valve is Edwards' most advanced transcatheter
aortic valve, and can be delivered through a low-profile 14 French
expandable sheath (eSheath). It also has an outer skirt – a
cuff of fabric surrounding the bottom of the frame – to provide a
seal to minimize paravalvular leak. The SAPIEN 3 valve can be
implanted via the transfemoral approach through an incision in the
leg, as well as alternative access approaches.
The SAPIEN 3 valve was approved in Europe in January
2014 for the treatment of high-risk and inoperable patients
with severe aortic stenosis. It is not approved for the
treatment of intermediate risk patients in Europe. The valve is an investigational device
not yet available commercially in the United States.
Clinical Outcomes at 30 Days with the SAPIEN 3 Valve
(As-Treated)
|
SAPIEN 3 High-Risk
(n=583)
Average age: 82.6
years
Average STS score:
8.6%
|
SAPIEN 3
Intermediate-Risk (n=1,076)
Average age: 81.9
years
Average STS score:
5.3%
|
Outcome
|
All
|
Transfemoral
|
Transapical/transaortic
|
All
|
Transfemoral
|
Transapical/transaortic
|
All-cause mortality -
%
|
2.2
|
1.6
|
5.4
|
1.1
|
1.1
|
1.6
|
Stroke: all -
%
|
1.54
|
1.63
|
1.09
|
2.6
|
2.42
|
4.00
|
Stroke: disabling -
%
|
0.86
|
0.81
|
1.09
|
1.02
|
0.95
|
1.60
|
Financial Outlook
As previously communicated, Edwards continues to plan for U.S.
regulatory approval and launch of SAPIEN 3 early in 2016. The
company is not updating its sales and earnings per share guidance
for 2015. Edwards' projected 2015 diluted earnings per share
of $4.00-4.30, excluding special
items, reflects the expected reduction in reported sales due to
changes in currency exchange rates, mitigated by currency hedge
contracts and the benefit of the company's natural hedges. If
currencies remain at current levels, most of the benefit of the
currency hedge contracts would not recur in 2016.
Edwards is conducting an analyst update on Sunday, March 15, 2015, at 6:30 pm. This event will be accessible via live
webcast at http://ir.edwards.com/eventdetail.cfm?EventID=157556 and
available for replay on the "Investor Relations" section of the
Edwards web site.
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
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 of Dr.
Kodali, statements regarding the launch status, availability and
benefits of SAPIEN 3, and financial guidance in the "Financial
Outlook" section. 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, unanticipated clinical
outcomes after longer-term patient experience and follow-up, and
unexpected regulatory actions, competitive activity, or quality or
manufacturing 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, 2014.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN 3, SAPIEN, SAPIEN 3 and PARTNER are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
Non-GAAP Financial
Information
To supplement the consolidated financial results prepared in
accordance with Generally Accepted Accounting Principles ("GAAP"),
the Company uses non-GAAP financial measures. Our
projection for diluted earnings per share is provided on a non-GAAP
(or "excluding special items") basis and excludes the gains and
losses from special items such as significant investments,
litigation, and business development transactions due to the
inherent difficulty in forecasting such items. The Company is
not able to provide a reconciliation of these non-GAAP items, to
expected reported results due to the unknown effect, timing and
potential significance of special charges or gains, and
management's inability to forecast charges associated with future
transactions and initiatives. Management does not consider the
excluded items or adjustments as part of day-to-day business or
reflective of the core operational activities of the Company as
they result from transactions outside the ordinary course of
business.
Management uses non-GAAP financial measures internally for
strategic decision making, forecasting future results and
evaluating current performance. These non-GAAP financial
measures are used in addition to and in conjunction with results
presented in accordance with GAAP and reflect an additional way of
viewing aspects of the Company's core operations that, when viewed
with its GAAP results, provide a more complete understanding of
factors and trends affecting the Company's business. Non-GAAP
financial measures are not prepared in accordance with GAAP;
therefore, the information is not necessarily comparable to other
companies and should be considered as a supplement to, and not as a
substitute for, or superior to, the corresponding measures
calculated in accordance with GAAP.
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