Edwards' SAPIEN XT Valve Approved in Europe for Transcatheter Mitral and Aortic Valve-in-Valve Procedures
February 05 2014 - 9:15AM
Marketwired
Edwards' SAPIEN XT Valve Approved in Europe for Transcatheter
Mitral and Aortic Valve-in-Valve Procedures
IRVINE, CA--(Marketwired - Feb 5, 2014) - 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
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