Edwards Receives FDA Approval to Expand U.S. Clinical Trial of Next-Generation Transcatheter Valve
November 07 2011 - 9:00AM
Marketwired
Edwards Lifesciences Corporation (NYSE: EW), the global leader in
the science of heart valves and hemodynamic monitoring, today
announced that the U.S. Food and Drug Administration (FDA)
conditionally approved the addition of a second treatment group to
The PARTNER II Trial, which is studying the company's
next-generation Edwards SAPIEN XT transcatheter heart valve.
This new cohort (Cohort A) of The PARTNER II Trial is a
non-inferiority study of up to 2,000 patients with severe,
symptomatic aortic valve stenosis who have an elevated risk for
traditional open-heart surgery (Society of Thoracic Surgeons score
>4), which is a lower risk profile than those who were enrolled
in The PARTNER Trial. Patients will be evenly randomized to receive
the Edwards SAPIEN XT valve or surgery. Those undergoing
transcatheter valve replacement will be treated either
transfemorally (via the femoral artery) or transapically (via a
small incision between the ribs). The primary endpoint to be
evaluated is a composite of death and major stroke at two years,
with secondary endpoints that include valve performance and
quality-of-life indicators.
"Based on the favorable outcomes in The PARTNER Trial, we are
pleased to be able to study our next-generation valve platform in
an expanded patient population that can benefit from a
less-invasive therapy," said Larry L. Wood, Edwards' corporate vice
president, transcatheter valve replacement. "The success of this
trial would support the use of the transcatheter therapy in a
broader group of patients."
Edwards hopes to complete enrollment in the first cohort (Cohort
B) of this trial around year-end. Data from this cohort of
inoperable patients is intended to support U.S. commercial approval
of the Edwards SAPIEN XT valve.
The Edwards SAPIEN XT valve is commercially available in Europe,
where it received a CE Mark in March 2010. The Edwards SAPIEN XT
transcatheter valve is an investigational device in the U.S. and is
not yet available commercially.
About Edwards Lifesciences Edwards
Lifesciences is the global leader in the science of heart valves
and hemodynamic monitoring. Driven by a passion to help patients,
the company partners with clinicians to develop innovative
technologies in the areas of structural heart disease and critical
care monitoring that enable them to save and enhance lives.
Additional company information can be found at 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 statements of Mr. Wood
and statements regarding the timing, progress and potential
outcomes 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. 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
those expressed or implied by the forward-looking statements based
on a number of factors including but not limited to unexpected
delays in clinical trial enrollments, changes in regulatory
requirements or trial outcomes. These factors 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, 2010.
Edwards and Edwards SAPIEN XT are trademarks of Edwards
Lifesciences Corporation. Edwards Lifesciences, the stylized E logo
and PARTNER are trademarks of Edwards Lifesciences Corporation and
are registered in the United States Patent and Trademark
Office.
Media Contact: Sarah Huoh Janet Kim 949-250-5070
Investor Contact: David K. Erickson 949-250-6826
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