Edwards' SAPIEN XT Valve Approved in Europe for Transcatheter Mitral and Aortic Valve-in-Valve Procedures

Edwards' SAPIEN XT Valve Approved in Europe for Transcatheter Mitral and Aortic 
Valve-in-Valve Procedures 
IRVINE, CA -- (Marketwired) -- 02/05/14 --  Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced it has received CE
Mark in Europe for valve-in-valve procedures using the SAPIEN XT
transcatheter heart valve, providing a minimally invasive treatment
option for patients whose surgical mitral or aortic valves require
replacement, and who are at extreme risk for surgery. Edwards is the
only company to receive a valve-in-valve indication for the mitral
position, which addresses an unmet need within the clinical community
to provide an alternative to a high-risk surgery. 
"The European approval of the SAPIEN XT system for valve-in-valve
procedures is a milestone achievement. While this is not a large
financial opportunity, it represents an important benefit for
patients unable to go through a second open-heart surgery to replace
their failing bioprosthetic valves," said Larry L. Wood, Edwards'
corporate vice president, transcatheter heart valves.  
More than 300,000 valve replacements are performed worldwide each
year through open-heart surgery, utilizing either bioprosthetic
tissue valves or mechanical valves. Edwards' proven family of
PERIMOUNT bovine pericardial tissue valves have been the world's most
frequently implanted valves for more than 30 years, which surgeons
have increasingly chosen over mechanical valves, even in younger
patients. Patients who receive Edwards' bovine pericardial valves are
generally not required to be on lifelong anticoagulation therapy
(blood thinners), as they would if they had received a mechanical
valve. Decades of clinical experience and peer-reviewed data on
Edwards' valves provide robust evidence of long-term performance and
optimal hemodynamics of the PERIMOUNT valve platform.  
"Just as native heart valves experience wear over time, bioprosthetic
valves eventually degenerate, too, creating a need for a replacement
valve," said Olaf Wendler, M.D., Ph.D., professor of cardiac surgery,
King's College Hospital in London, and one of the principal
investigators of the SOURCE XT Registry. "The European adoption of
valve-in-valve procedures using SAPIEN XT is an important development
for treating patients who may otherwise go untreated. In particular,
patients needing a re-operation to address a failing mitral valve
face a very challenging surgery, and the ability to offer a
transcatheter replacement is extremely important for this patient
group." Dr. Wendler provides paid consulting services to Edwards for
education, and research and development of transcatheter valve
technologies. 
In the United States, the SAPIEN XT valve is not commercially
available; it is an investigational device being studied as part of
the randomized, pivotal 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, statements of Mr. Wood
and Dr. Wendler and statements about treatment trends and potential
patient benefits. 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 outcomes after more extended
clinical experience, unanticipated regulatory or quality issues, and
changes in patient and market dynamics. 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,
SAPIEN, SAPIEN XT, PARTNER and PARTNER II are trademarks of Edwards
Lifesciences Corporation.  
Media Contact: 
Sarah Huoh
949-250-5070 
Investor Contact: 
David K. Erickson
949-250-6826 
 
 
Press spacebar to pause and continue. Press esc to stop.