Lower-Profile SAPIEN XT Transcatheter Heart Valve Associated With Improved Procedural Outcomes

Lower-Profile SAPIEN XT Transcatheter Heart Valve Associated With Improved 
Procedural Outcomes 
Preliminary Results From Inoperable Cohort of The PARTNER II Trial
Presented at ACC 2013 
SAN FRANCISCO, CA -- (Marketwire) -- 03/10/13 --   Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the science
of heart valves and hemodynamic monitoring, announced that
preliminary results from The PARTNER II Trial demonstrated similar
one-year outcomes in mortality and major clinical events between the
Edwards SAPIEN XT transcatheter aortic valve and the Edwards SAPIEN
valve, yet fewer vascular events with the lower-profile SAPIEN XT
valve. These data from The PARTNER II Trial studying transcatheter
aortic valve replacement (TAVR) in inoperable patients with severe,
symptomatic aortic stenosis were presented today as a late-breaking
clinical trial at the American College of Cardiology's (ACC) 62nd
Annual Scientific Session in San Francisco.  
"We are very pleased to see improved outcomes in both the SAPIEN and
SAPIEN XT patients, as compared to results from earlier trials," said
Larry L. Wood, Edwards' corporate vice president, transcatheter heart
valves. "The SAPIEN XT valve was designed to reduce complications of
the TAVR procedure, and we believe this has been demonstrated by
today's results. Edwards is proud to lead the advancement of
cutting-edge innovations for these high-risk patients, supported by
rigorous clinical evidence." 
The PARTNER II Trial enrolled 560 patients deemed inoperable for
traditional open-heart surgery at 28 hospitals in the United States
between April 2011 and February 2012. Patients were randomized to
receive one of the two Edwards transcatheter aortic heart valves: 276
received the SAPIEN valve, and 284 received the SAPIEN XT valve.  
The FDA approved the SAPIEN valve in November 2011 for the treatment
of inoperable patients, and expanded the indication to high-risk
surgical patients in October 2012. The SAPIEN XT valve is an
investigational device not yet available commercially in the United
States.  
Edwards anticipates submitting data from the inoperable cohort
(Cohort B) of The PARTNER II Trial to the United States Food and Drug
Administration (FDA) in the second quarter. The company expects to
complete enrollment in the intermediate risk cohort (Cohort A) of The
PARTNER II Trial mid-year.  
The PARTNER II Trial, Inoperable Cohort (Cohort B) (i) 


 
                                                                            
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                                     30-day                  1-year         
----------------------------------------------------------------------------
Outcome                      SAPIEN                  SAPIEN                 
                               XT    SAPIEN  p value   XT    SAPIEN  p value
----------------------------------------------------------------------------
All-cause mortality - %        3.5     5.1    0.36    22.5    23.7    0.706 
----------------------------------------------------------------------------
Stroke: all - %                4.3     4.1    0.88     5.9     5.7    0.935 
----------------------------------------------------------------------------
Vascular events: major - %     9.6    15.5    0.04                          
----------------------------------------------------                        
Vascular events: minor - %     5.0     7.4    0.23                          
----------------------------------------------------                        

 
Background Information on The PARTNER Trial, Inoperable Cohort (Cohort
B) 
The PARTNER Trial studied 358 patients with severe, symptomatic
aortic stenosis deemed inoperable for traditional open-heart surgery,
and enrolled between April 2007 and March 2009. Patients were evenly
randomized to receive either the Edwards SAPIEN valve or standard
therapy. Please note that the results from The PARTNER Trial and The
PARTNER II Trial are not directly comparable.  


 
                                                                            
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                                  30-day                    1-year          
----------------------------------------------------------------------------
Outcome                          Standard                  Standard         
                         SAPIEN  therapy  p value  SAPIEN  therapy  p value 
----------------------------------------------------------------------------
All-cause mortality - %    5.0     2.8      0.41    30.7     50.7  < 0.0001
----------------------------------------------------------------------------
Stroke: all - %            6.7     1.7      0.03    10.6     4.5      0.04  
----------------------------------------------------------------------------
Vascular events: all - %  30.7     5.0   < 0.0001                          
--------------------------------------------------                          

 
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 that enable 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 made by Mr.
Wood, statements regarding future potential and benefits of the
Edwards SAPIEN XT valve and expectations regarding the timing of FDA
submissions and clinical trial enrollment. 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 the outcomes 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 market developments
or delays in clinical trial enrollment or regulatory submissions, or
unanticipated outcomes of longer-term clinical trial or commercial
experience or final adjudication of the clinical trial results. 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, Edwards SAPIEN,
Edwards SAPIEN XT, PARTNER, PARTNER II, SAPIEN and SAPIEN XT are
trademarks of Edwards Lifesciences Corporation.  
(i) All percents for mortality and stroke data in this press release
are Kaplan-Meier estimates. 
Media Contact:  
Sarah Huoh
949-250-5070 
Investor Contact:  
David K. Erickson
949-250-6826