Edwards Lifesciences Reports Positive Data From Its Largest
Transcatheter Valve Implant Series
BARCELONA, SPAIN -- (MARKET WIRE) -- 05/20/09 -- Edwards
Lifesciences Corporation (NYSE: EW), the world leader in the science
of heart valves, today announced at EuroPCR 2009 the results from its
first post-market study of consecutively enrolled Edwards SAPIEN
transcatheter aortic valve patients. The data demonstrated the
successful commercialization of the Edwards SAPIEN valve with high
device success and low 30-day mortality.
The SOURCE serial registry reported results on 1,038 patients, or 100
percent of patients treated with the Edwards SAPIEN valve at 32
European commercial centers from November 2007 to January 2009. The
data showed a 30-day survival rate of 93.7 percent in transfemoral
procedures (valve delivered via the femoral artery), and 89.7 percent
in transapical procedures (valve delivered via a small incision
between the ribs) -- rates that were better than the predicted
surgical survival in this high-risk patient cohort. Implant
procedure safety with the Edwards SAPIEN valve was strongly
demonstrated with low incidences of valve malposition (1.5 percent),
coronary obstruction (0.6 percent), stroke (2.5 percent), conversion
to surgery (2.7 percent), need for permanent pacemaker (7 percent),
and significant aortic regurgitation (4.7 percent).
"SOURCE sets a new standard for the evaluation of the commercial
experience of transcatheter aortic valve implantation in a high-risk
patient population. In order to preserve the integrity of the study
data, each adverse event was individually reviewed by the study's
principal investigators. Additionally, to avoid patient selection
bias, those centers unable to provide all data on all patients were
excluded from the report," said Martyn Thomas, M.D., director of
cardiothoracic services, Guys and St. Thomas' NHS Foundation Trust in
London, and a paid consultant to Edwards. "This approach provided
the opportunity to accurately evaluate both the effectiveness of
training and the commercial launch experience of the Edwards SAPIEN
valve, and will guide clinical practice."
Also presented today was the first complete six-month data set of the
130 patients enrolled in the PARTNER EU clinical trial. The data
demonstrated strong hemodynamics and valve performance through
measurements including effective orifice area and ejection fraction,
as well as 100 percent freedom from structural valve deterioration.
PARTNER EU was designed to evaluate the Edwards SAPIEN valve in a
setting where, for the first time, an interventional cardiologist and
cardiac surgeon partnered to screen and determine the correct
treatment approach for each patient. The study was conducted in
Europe from April 2007 through January 2008, and provided valuable
lessons about patient selection that were incorporated into SOURCE
and the PARTNER Investigational Device Exemption (IDE) Trial.
"We are very proud of the robust clinical results presented today at
EuroPCR, and the rigorous scientific approach we have taken in the
study of this transcatheter valve," said Michael A. Mussallem,
Edwards' chairman and CEO. "In particular, the 30-day results for
the initial commercial experience with the Edwards SAPIEN valve
validate the effectiveness of the valve and its two delivery options,
as well as the strength of the physician partnership approach."
Representatives from Edwards are at Booth #F02 at EuroPCR 2009
through May 22. Simulators in the EuroPCR 2009 Training Village will
provide an opportunity for a virtual procedural experience with the
Edwards SAPIEN valve delivered via 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 an investigational device being studied
as part of the PARTNER Trial, the world's only randomized controlled
clinical trial of a transcatheter aortic heart valve.
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 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, RetroFlex, 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
solely responsible for the content of this announcement.
