Diabetic Patients at High Risk for Aortic Valve Surgery Experienced Lower All-Cause Mortality When Treated With SAPIEN Valve

Diabetic Patients at High Risk for Aortic Valve Surgery Experienced Lower All-Cause Mortality When Treated With SAPIEN Valve 
AMSTERDAM, THE NETHERLANDS -- (Marketwired) -- 09/03/13 --  Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the science
of heart valves and hemodynamic monitoring, today announced that a
new post-hoc data analysis from The PARTNER Trial demonstrated that
diabetic patients with aortic stenosis in need of heart valve
replacement, but at high surgical risk, experienced a 35 percent(1)
lower relative all-cause mortality one year after treatment with
transcatheter aortic valve replacement (TAVR), as compared to those
treated with surgical aortic valve replacement (AVR). 
The data analysis was presented today at the ESC Congress 2013 in
Amsterdam by Brian Lindman, M.D., assistant professor of medicine,
cardiovascular division, at Washington University School of Medicine
in St. Louis.  
"While this was not a pre-specified analysis of the trial and should
be considered hypothesis generating, our study raises the possibility
that TAVR may be the preferred approach for diabetic patients with
severe symptomatic aortic stenosis who are at high surgical risk,"
said Lindman, who participated in The PARTNER Trial as a clinical
investigator.  
In the analysis of diabetic patients in the as-treated high-risk
cohort of The PARTNER Trial, one-year all-cause mortality was 18
percent for patients treated with the Edwards SAPIEN valve delivered
via the femoral artery or a small incision between the ribs, and 27.4
percent for patients treated with surgical aortic valve replacement.
Additionally, the analysis showed that diabetic patients treated with
TAVR experienced quicker quality of life improvement and lower
one-year rates of renal failure than those treated with surgery.  
The PARTNER Trial is the first randomized, controlled trial of a
transcatheter aortic valve in the United States. The trial's
high-risk cohort (Cohort A) included an as-treated population of 657
patients with severe, symptomatic aortic stenosis deemed at high risk
for traditional open-heart surgery. Of those, 275 were diabetic and
treated with either TAVR (n=145) or surgical AVR (n=130). The
post-hoc analysis did not account for diabetic medications,
severity/duration of
 diabetes, microvascular complications or glucose
control. Lindman concluded that further studies are needed to
understand how insulin treatment or the presence of metabolic
syndrome may influence outcomes. 
The Food and Drug Administration (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. 
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, Dr. Lindman's statements.
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, the possibility that future clinical
could yield different 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,
PARTNER and SAPIEN 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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