Edwards Lifesciences Announces First Human Implants With 18 French
Transcatheter Valve System
IRVINE, CA--(Marketwire - May 14, 2009) - Edwards Lifesciences
Corporation (NYSE: EW), the world leader in the science of heart
valves, today announced the successful completion of the first human
implants of its next-generation transcatheter aortic heart valve used
with its new 18 French delivery system. Edwards expects these cases,
performed in Canada, to be reviewed next week at EuroPCR 2009.
The 18 French system features the Edwards SAPIEN XT valve paired with
its new, smaller NovaFlex transfemoral delivery system. The valve has
a cobalt chromium alloy balloon-expandable frame, which allows for a
significant reduction in its profile, and bovine pericardial tissue
leaflets processed in the same stringently controlled manner as
Edwards' market-leading surgical heart valves. The NovaFlex delivery
system leverages the ease-of-use features of the Edwards RetroFlex
line of delivery systems.
"The clinical success of the Edwards SAPIEN valve has allowed us to
treat patients who previously had no good treatment options. The new
Edwards SAPIEN XT valve, with its improved design and revolutionary
lower profile delivery system, will allow us to treat aortic stenosis
patients even more reliably and safely," said John Webb, M.D., who
performed the first successful human implants of the new
transcatheter system. Webb is director of the cath lab and cardiac
intervention at St. Paul's Hospital in Vancouver, British Columbia,
and a consultant to Edwards Lifesciences.
While the Edwards SAPIEN XT valve is being evaluated in the PREVAIL
EU trial for CE Mark approval, the commercial rollout of Edwards'
RetroFlex 3 delivery system to be used with the Edwards SAPIEN valve
is underway in Europe. The RetroFlex 3 delivery system is designed to
optimize physician control of valve navigation and facilitate
crossing of the patient's native calcified aortic valve.
"We are dedicated to leading the rapid advancement of transcatheter
heart valve technology," said Larry L. Wood, Edwards' corporate vice
president, transcatheter valve replacement. "The commercial launch of
the RetroFlex 3 delivery system and the enhancements incorporated
into the NovaFlex delivery system with the Edwards SAPIEN XT valve
are designed to make transcatheter valve therapy accessible to even
more patients."
Representatives from Edwards will be at Booth #F02 at EuroPCR 2009,
May 19-22 in Barcelona, Spain. Simulators in the EuroPCR 2009
Training Village will provide the opportunity for a virtual
procedural experience with the RetroFlex 3 transfemoral and Ascendra
transapical delivery systems.
The Edwards SAPIEN valve is approved for commercial sale in Europe.
In the United States, it is being studied as part of a randomized,
pivotal clinical trial.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart
valves and hemodynamic monitoring, with more than five decades of
experience in partnering with clinicians to develop life-saving
innovations. Headquartered in Irvine, Calif., Edwards treats advanced
cardiovascular disease with its market-leading heart valve therapies,
and critical care and vascular technologies, which are sold in
approximately 100 countries. The company's global brands include
Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac,
Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company
information can be found at http://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, the timing and progress
of clinical studies relating to the company's transcatheter valve
technologies and the market opportunity for transcatheter
technologies. 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 actual results or experience to differ materially from that
expressed or implied by the forward-looking statements. Factors that
could cause actual results or experience to differ materially from
that expressed or implied by the forward-looking statements 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, 2008.
Edwards, Edwards SAPIEN XT, NovaFlex and RetroFlex 3 are trademarks
of Edwards Lifesciences Corporation. Edwards Lifesciences, the
stylized E logo, Ascendra, Carpentier-Edwards, Cosgrove-Edwards,
Edwards SAPIEN , FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz are
trademarks of Edwards Lifesciences Corporation and are registered in
the United States Patent and Trademark Office.
Media Contact:
Sarah Huoh
949-250-5070
Investor Contact:
David K. Erickson
949-250-6826
This announcement was originally distributed by Hugin. The issuer is
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