IRVINE, Calif., April 18, 2008 -- Edwards Lifesciences
Corporation (NYSE: EW), the world leader in the science of heart valves,
announced that yesterday the first patients were treated in a United States
feasibility study using the Edwards SAPIEN transcatheter heart valve in
addressing a congenital condition in which the valve between the right
ventricle and the pulmonary artery is nonfunctional.
"We were able to successfully implant the Edwards SAPIEN transcatheter
heart valve percutaneously in the first three patients treated in this trial.
All of the patients are recovering and are expected to go home today," said
Ziyad M. Hijazi, M.D., M.P.H., director of the Rush Center for Congenital and
Structural Heart Disease, chief of the section of pediatric cardiology and
professor in the departments of pediatrics and internal medicine at Rush
University, Chicago, and a paid consultant to Edwards Lifesciences. "Patients
with congenital right ventricular outflow tract problems typically face the
burden of multiple open-heart surgeries throughout their lives, either to
replace their 'native' diseased valves or, as they age, their bioprosthetic
replacement valves. This clinical study will enable physicians to offer a
minimally-invasive alternative to symptomatic patients with a failing
pulmonary valve conduit, giving them the opportunity to recover and resume
their normal activities."
The U.S. Food and Drug Administration (FDA) conditionally approved the
investigational device exemption (IDE) clinical trial in late 2007. The study
of 30 patients at three hospitals will enable the collection of safety and
effectiveness data, ultimately in support of a commercial approval
application.
In this transcatheter valve replacement procedure, the Edwards SAPIEN
bovine pericardial valve is compressed onto a balloon to the approximate
diameter of a pencil, threaded through the patient's circulatory system from
the leg using the RetroFlex transfemoral delivery system and deployed across
the patient's pulmonary valve. The valve replacement is accomplished as a
"beating heart" procedure, without requiring cardiopulmonary bypass or an
open-chest incision.
"Edwards is proud to have the opportunity to address this critical unmet
patient need and to offer these patients a far less traumatic treatment
option," said Larry L. Wood, Edwards' corporate vice president, transcatheter
valve replacement. "This therapy leverages all of our Edwards SAPIEN valve
platform technologies to help these congenital patients via a
minimally-invasive treatment alternative." Edwards' physician partners
performed the first U.S. transcatheter pulmonic case on a compassionate basis
in December 2005. All of the compassionate cases have been successful.
The Edwards SAPIEN transcatheter heart valve is also currently being
studied in the PARTNER (Placement of AoRTic traNscathetER valves) U.S. pivotal
trial for the treatment of patients with severe aortic heart valve stenosis (a
narrowing of the aortic valve that restricts blood flow), who are considered
to be high risk for conventional open-heart valve replacement surgery.
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 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.
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, Edwards SAPIEN and RetroFlex are trademarks of Edwards
Lifesciences Corporation. Edwards Lifesciences, the stylized E logo,
CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty,
PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences
Corporation and are registered in the United States Patent and Trademark
Office.
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