Survival Benefit With Edwards SAPIEN Valve Widens Further at

Survival Benefit With Edwards SAPIEN Valve Widens Further at Three
Years 
MIAMI, FL -- (Marketwire) -- 10/24/12 --  Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced three-year results
of a pivotal clinical study of inoperable patients with severe aortic
stenosis treated with the Edwards SAPIEN transcatheter heart valve.
The data from The PARTNER Trial (Cohort B) demonstrated a sustained
and increasing survival benefit for SAPIEN valve patients at three
years, as well as significantly less time spent in the hospital. The
new results were presented today at the 24th annual Transcatheter
Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by
the Cardiovascular Research Foundation. 
The three-year all-cause mortality rate for transcatheter aortic
valve replacement (TAVR) patients was 54.1 percent, as compared to
80.9 percent for those patients receiving standard therapy(i).
Despite the advanced age and comorbidities of this inoperable patient
population, the mortality rates in the third year of follow-up were
19.3 percent for TAVR patients and 40.3 percent for control. Also of
note, TAVR patients experienced a median period of time out of the
hospital that was more than two-and-a-half times longer than that of
standard therapy patients.(ii) 
There was a higher stroke rate in the transcatheter group as compared
to standard therapy, although the two additional events between the
second and third years of follow-up were adjudicated to not be
related to the procedure or the device. 
"We are very pleased that the inoperable patients in The PARTNER
Trial continued to experience benefits in all the key measures of
clinical outcomes. The performance and durability of the Edwards
SAPIEN valve also remained excellent," said Michael A. Mussallem,
Edwards' chairman and CEO. "The three-year data further highlight the
devastating effects of symptomatic severe aortic stenosis in patients
receiving only standard therapy -- reinforcing the important role
that transcatheter valve replacement plays in the treatment of these
patients." 
This trial studied 358 patients with severe, symptomatic aortic
stenosis deemed inoperable for traditional open-heart surgery.
Patients were evenly randomized to receive either the SAPIEN valve or
standard therapy. The United States Food and Drug Administration
(FDA) approved the SAPIEN valve in November 2011 for the treatment of
inoperable patients, and last week also approved SAPIEN for high-risk
surgical patients. 
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
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 made by Mr.
Mussallem and statements regarding future potential and benefits of
the Edwards SAPIEN 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 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 unanticipated outcomes of longer-term clinical trial and
commercial experience. 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, 2011. 
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN,
PARTNER and SAPIEN are trademarks of Edwards Lifesciences
Corporation.  
(i) All percents for mortality data in this press release are
Kaplan-Meier estimates.
 (ii) At three years, the median days alive
out of hospital were 944 [233-1096] for TAVR, and 368 [147-1096] for
standard therapy. 
Media Contact: 
Sarah Huoh or Janet Kim
949-250-5070 
Investor Contact: 
David K. Erickson
949-250-6826 
 
 
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