Positive Patient Outcomes at One Year With Edwards Sapien XT Transcatheter Valve

Positive Patient Outcomes at One Year With Edwards Sapien XT Transcatheter Valve 
PARIS -- (Marketwired) -- 05/21/13 --   Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that one-year data
from its European post-approval study of the Edwards SAPIEN XT
transcatheter aortic heart valve continued to demonstrate positive
patient outcomes, including all-cause mortality and complication
rates. Data from the SOURCE XT Registry documents the outcomes of
2,688 consecutively enrolled patients at 93 centers in Europe
performing transcatheter aortic valve replacement (TAVR). This
represents more than 20 percent of the total patients treated with
SAPIEN XT valves during the time period of this study. The data were
presented today at EuroPCR 2013 by Professor Stephan Windecker, M.D.,
chief of cardiology and director of invasive cardiology at University
Hospital InselSpital Bern, Switzerland. 
"We are very pleased that studies across geographies and in both
real-world and clinical trial settings continue to support the
benefits to patients of the lower-profile SAPIEN XT valve," said
Larry L. Wood, Edwards' corporate vice president, transcatheter valve
replacement. "This report from the SOURCE XT Registry confirms the
positive impact TAVR provides for patients' quality of life and heart
function, which is once again profound." 
The SOURCE XT Registry, a monitored and adjudicated prospective
registry, is studying the use of the Edwards SAPIEN XT valve in a
real-world commercial setting, treating high-risk and inoperable
patients with severe symptomatic aortic stenosis. The study cited
both the baseline and cardiovascular characteristics of the treated
patients in confirming their high risk profiles. Despite this patient
risk level, the one-year survival post-TAVR was 80.5 percent(1), and
freedom from important procedural complications was notable: the
study found that stroke occurred in 6.3 percent of patients, and it
was reported that 93.8 percent of patients had none/trace or mild
paravalvular aortic regurgitation.  
The presentation also addressed a segment of the treated patients
with a EuroScore of less than 15 percent, which primarily consisted
of patients who were deemed inoperable due to conditions such as
porcelain aorta, liver disease, frailty, cancer, dialysis and severe
pulmonary hypertension. 
The SOURCE XT Registry enrolled patients treated with the SAPIEN XT
valve in 17 countries between July 2010 and October 2011. Patients
were treated using a transfemoral (62.7 percent), transapical (33.3
percent), transaortic (3.7 percent) or subclavian (.3 percent)
approach and will be followed out to five years.  
The Edwards SAPIEN XT valve is an investigational device not yet
available commercially in the United States. It is currently being
evaluated in the U.S. in The PARTNER II Trial.  
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, Mr. Wood's comments and
statements regarding clinical programs. 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 results of expanded clinical
experience and unanticipated effects of regulatory, clinical and
quality systems. 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, 2012. 
Edwards, Edwards Lifesciences, the stylized E logo and Edwards SAPIEN
XT are trademarks of Edwards Lifesciences Corporation. 
(1) All percents for data in this press release are Kaplan-Meier
estimates. 
Media Contact:  
Sarah Huoh
949-250-5070 
Investor Contact:
David K. Erickson
949-250-6826 
 
 
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