Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
05/09/2007 12:06
PR Newswire
IRVINE, California, September 5 /PRNewswire/ --
Edwards Lifesciences Corporation (NYSE: EW), the world leader in the
science of heart valves, today announced that it has received CE Mark
approval for European commercial sales of its Edwards SAPIEN transcatheter
aortic heart valve technology with the RetroFlex transfemoral delivery
system.
The Edwards SAPIEN transcatheter heart valve is implanted via a
minimally-invasive procedure, without requiring open-heart surgery. It is
the first transcatheter bovine pericardial valve incorporating technological
advancements and design elements that allow for greater ease of implantation
by physicians. The valve is designed to treat patients with severe aortic
heart valve stenosis (a narrowing of the valve that restricts blood flow),
who are considered to be high-risk or non-operable for conventional
open-heart valve replacement surgery.
"This is a landmark achievement for this transformational technology,
which holds promise for the large number of high-risk patients suffering from
severe aortic stenosis," said Michael A. Mussallem, Edwards Lifesciences'
chairman and CEO. "As the global leader in heart valve therapy, we are
committed to working closely with our European clinical partners on this
transcatheter technology, in order to provide optimal clinical outcomes for
the many high-risk patients in need of aortic valve replacements, who might
otherwise have limited or no treatment options."
"In this pioneering procedure, the skill sets of the surgeon and the
interventional cardiologist complement each other to provide for better
patient care," said Martin B. Leon, MD, Professor of Medicine and Associate
Director of the Center for Interventional Vascular Therapy at Columbia
University Medical Center and the principal investigator for the Edwards
PARTNER pivotal trial in the United States. "Several years of clinical
experience have demonstrated that optimal outcomes can be achieved with a
collaborative, multi-disciplinary team."
The Edwards SAPIEN transcatheter heart valve integrates
balloon-expandable stent technology that leverages Edwards' proprietary
bovine pericardial tissue and 30 years of design and manufacturing expertise.
With the RetroFlex transfemoral delivery system, the Edwards SAPIEN valve is
compressed onto the balloon to the approximate diameter of a pencil and
threaded through the patient's circulatory system from the leg and expanded
securely into place directly over the diseased aortic valve.
Edwards has achieved almost 500 implants of the transcatheter heart valve
through a series of extensive clinical trials and feasibility studies in
Europe, the U.S. and Canada. The company is proceeding on schedule with
European launch preparations, including establishing training centers,
selecting proctors for commercial site training, and progressing
country-specific reimbursement plans, and will begin selling the device,
as planned, in the fourth quarter of 2007.
The company has also submitted for CE Mark approval the Edwards SAPIEN
transcatheter heart valve with the Ascendra transapical delivery system -- in
which the valve is inserted between the ribs -- providing interventional
cardiologists and surgeons with a second valve delivery option. The Ascendra
transapical delivery system is expected to receive CE Mark by the end of the
year.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular disease
treatments, is the number-one heart valve company in the world and the global
leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif.,
Edwards focuses on specific cardiovascular disease states including heart
valve disease, peripheral vascular disease and critical care technologies.
The company's global brands, which are sold in approximately 100 countries,
include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent,
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 timely regulatory approval of the Edwards SAPIEN
transcatheter aortic heart valve; the timing and progress of clinical studies
relating to the company's transcatheter valve technologies and the market
opportunity for these products; the expected European launch of the Edwards
SAPIEN valve and the anticipation of beginning sales in fourth quarter of
2007; and the market 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, 2006.
Ascendra, Edwards, Edwards SAPIEN and RetroFlex are trademarks of Edwards
Lifesciences Corporation. Edwards Lifesciences, the stylized E logo,
Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT,
PERIMOUNT Magna, and Swan-Ganz are trademarks of Edwards Lifesciences
Corporation and are registered in the United States Patent and Trademark
Office. LifeStent is a trademark of Edwards Lifesciences AG and registered in
the United States Patent and Trademark Office.
Web site: http://www.edwards.com
Media, Sarah Huoh, +1-949-250-5070, or Investors, David K. Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation