Edwards Receives European Approval for Advanced SAPIEN 3 Valve
January 27 2014 - 9:15AM
Marketwired
Edwards Receives European Approval for Advanced SAPIEN 3 Valve
IRVINE, CA--(Marketwired - Jan 27, 2014) - Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that it has
received CE Mark in Europe and is initiating the launch of its most
advanced transcatheter aortic valve, the Edwards SAPIEN 3
valve.
The SAPIEN 3 valve builds upon Edwards' decades of experience in
the development of tissue heart valves, and the proven benefits of
the Edwards SAPIEN valves. The new valve has an outer skirt --
a cuff of fabric surrounding the valve frame -- providing a seal to
address paravalvular leak. The effectiveness of this solution
is supported by the limited clinical experience1, 2, as detailed in
two first-in-human feasibility studies, which demonstrated that
significant paravalvular leak was eliminated during transcatheter
aortic valve implantation (TAVI).
The SAPIEN 3 valve is the only commercial transcatheter heart
valve that can be delivered through a low-profile 14 French
expandable sheath (eSheath), which has shown through early clinical
experience a low rate of complications1, 2. The valve can be
implanted through multiple approaches: transfemoral, transapical or
transaortic. Once implanted, the discreet valve anchors in the
aortic annulus.
"European physicians have been eagerly awaiting the launch
of the Edwards SAPIEN 3 valve, and we are very excited to make it
available today. It has a unique design intended to provide a
simpler procedure, along with fewer post-procedural complications
and a faster recovery for patients," said Larry L. Wood, Edwards'
corporate vice president, transcatheter heart valves. "Based
on our clinical leadership in transcatheter heart valves, we
believe the SAPIEN 3 valve's characteristics and procedural
refinements have the potential to transform TAVI for both
physicians and patients."
In the United States, the Edwards SAPIEN 3 valve is an
investigational device being studied in the PARTNER II Trial and is
not yet available for sale in the country.
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, Mr.
Wood's statements and statements regarding the expected launch of
the Edwards SAPIEN 3 valve, design features and expected product
benefits and procedural outcomes. 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 roll-out and benefits of the technology 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 expanded clinical experience,
unexpected changes or delays related to product supply, potentials
for unexpected regulatory or quality developments, and customer
acceptance. 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 XT, SAPIEN 3, eSheath, PARTNER and PARTNER II are
trademarks of Edwards Lifesciences Corporation.
1 Binder RK, Rodés-Cabau J, Wood DA, et al. Transcatheter Aortic
Valve Replacement With the SAPIEN 3: A New Balloon-Expandable
Transcatheter Heart Valve. J Am Coll Cardiol Intv.
2013;6(3):293-300. doi:10.1016/j.jcin.2012.09.019.
2 Dvir D, Barbanti M, De Larochelliere R, et al. TCT-787
Preliminary Clinical Experience using the SAPIEN 3 device. J Am
Coll Cardiol. 2013;62(18_S1):B239.
doi:10.1016/j.jacc.2013.08.1539.
Media Contact: Sarah Huoh 949-250-5070 Investor Contact: David
K. Erickson 949-250-6826
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