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Edwards Lifesciences' New Transcatheter Heart Valve Data Demonstrate Positive Results
(Marketwire Via Acquire Media NewsEdge) WASHINGTON, DC, October 13 / MARKET WIRE/ --
Edwards Lifesciences Corporation (NYSE: EW),
the world leader in the science of heart valves, announced that new data
from two studies of the Edwards SAPIEN transcatheter aortic heart valve
with the RetroFlex transfemoral delivery system were presented today at the
20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific
symposium, sponsored by the Cardiovascular Research Foundation.
The 30-day results from the European post-CE Mark SOURCE registry of 303
transfemoral patients demonstrated a survival rate of 94 percent. SOURCE is
designed to evaluate the use of the Edwards SAPIEN valve in a hospital's
first 10 commercial cases, following Edwards' prescribed training program.
The majority of the SOURCE cases at 34 independent cardiac intervention
centers were not proctored.
The second study, PARTNER EU, is an observational multi-center study
conducted in Europe from April 2007 through January 2008 that enrolled 54
transfemoral patients. Interim follow-up results demonstrated a 92 percent
survival rate at 30 days and 90 percent survival at six months. Had these
very ill patients been treated with traditional open-heart surgery, the
30-day predicted survival would have been 75 percent.
"The data from the European commercial launch of the Edwards SAPIEN
transcatheter valve with the transfemoral delivery system have exceeded our
expectations," said Michael A. Mussallem, Edwards' chairman and CEO.
"Considering the high-risk characteristics of this patient population and
the demonstrated outcomes, we believe transcatheter valve replacement is a
viable treatment option. We are proud of the results, which can be
attributed to the valve technology, our comprehensive training program and
the dedication of the physicians involved in the studies."
Separately, in the United States, Edwards is the only company to currently
have underway a pivotal clinical trial of a transcatheter aortic valve
replacement. This multi-center study includes both transfemoral (from the
leg) and transapical (between the ribs) delivery systems for the
transcatheter valve replacement. Edwards is also the only company to have
both delivery system approaches for this procedure; valve delivery with
either approach is performed while the heart continues to beat and without
open-heart surgery or cardiopulmonary bypass.
The Edwards SAPIEN transcatheter heart valve is approved for commercial
sale in Europe. In the United States, it is an investigational device that
is not available for sale.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves
and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards
treats advanced cardiovascular disease with its market-leading heart valve
therapies, and critical care and vascular technologies. In 2008, Edwards
celebrates 50 years of partnering with clinicians to develop life-saving
innovations. The company's global brands, which are sold in approximately
100 countries, include CardioVations, Carpentier-Edwards, Cosgrove-Edwards,
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. 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.
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, 2007.
Edwards and RetroFlex are trademarks of Edwards Lifesciences Corporation.
Edwards Lifesciences, the stylized E logo, 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. CardioVations
is a trademark of Edwards Lifesciences AG and is registered in the United
States Patent and Trademark Office.
Media Contact:
Sarah Huoh
949-250-5070
Investor Contact:
David K. Erickson
949-250-6826
Copyright ? 2008 Marketwire
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