EDWARDS INTUITY Valve Data Demonstrate Improved Patient Benefits Over Standard
TORONTO, ON -- (Marketwired) -- 04/30/14 -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that three-year
clinical outcomes of its EDWARDS INTUITY valve platform demonstrated
improved cardiac and valvular performance, as well as patient
These new data from the TRITON(1) Trial were presented at the
American Association for Thoracic Surgery's (AATS) 94th Annual
Meeting in Toronto, Canada, by Thorsten Wahlers, M.D., Ph.D.,
Hospital and Health Center for Heart and Thoracic Surgery, University
Clinic, Cologne, Germany.
The interim analysis of 287 patients who underwent aortic valve
replacement with the EDWARDS INTUITY platform included 138 that
received the next-generation EDWARDS INTUITY Elite rapid-deployment
valve. The EDWARDS INTUITY valve platform combines the proven
Carpentier-Edwards PERIMOUNT design with a balloon-expandable,
cloth-covered frame, which enables the use of fewer sutures during
valve replacement surgery.
"There is evidence from our experience that the expansion of the
frame during valve implantation can potentially widen and reshape a
narrowed left ventricular outflow tract, which directs blood flow
into the aortic valve. This patient benefit was demonstrated in our
study through clinically significant reductions in aortic valve mean
pressure gradient and left ventricular size," said Dr. Wahlers. "This
design element also helped clinicians better select a valve size most
appropriate for the patient, which can be a challenge with
conventional valves, and enabled more efficient blood flow through
At three years, the study reported that rapid deployment aortic valve
replacement using the EDWARDS INTUITY valve platform in patients with
aortic stenosis was associated with beneficial outcomes including:
-- Statistically significantly hemodynamic performance improvement of the
bioprosthetic valve, as indicated by a low aortic valve (AV) pressure
gradient (mean 8.7 mmHg overall); and
-- Improved heart function, as demonstrated by a statistically
significant reduction in left ventricular size over time (16 perce
reduction in mean LV mass index).
"We are pleased that these data demonstrated important advantages that
were meaningful for patients, which is significant given that the
EDWARDS INTUITY valve platform is built on the proven
Carpentier-Edwards PERIMOUNT heart valve design and represents a new
procedural approach to aortic valve surgery. We are continuing our
launch of the EDWARDS INTUITY Elite valve in Europe, to provide a new
treatment option for surgeons that is built on a surgical valve
platform they trust," said Donald E. Bobo, Jr., Edwards' corporate
vice president, heart valve therapy.
The EDWARDS INTUITY Elite valve platform is currently being studied
as part of the TRANSFORM Trial, the first U.S. clinical trial of a
rapid deployment aortic valve replacement. It is an investigational
device and not yet available for sale or use in the United States.
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, enabling them to save and
enhance lives. Additional company information can be found at
(1) The TRITON Trial involved six European centers and treated a
total of 287 patients with the EDWARDS INTUITY platform between Jan.
2010 and Oct. 2012.
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, Dr. Wahler's and Mr.
Bobo's statements and statements regarding design features and
expected product benefits and procedural outcomes from the EDWARDS
INTUITY Elite Valve System. 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 the roll-out and benefits of the technology 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 outcomes after expanded and extended clinical experience,
unexpected changes or delays related to product supply, quality and
availability, changes in product indications or reimbursement levels,
or regulatory decisions. 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, 2013.
Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS INTUITY,
EDWARDS INTUITY Elite, Carpentier-Edwards, PERIMOUNT and TRANSFORM
are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
David K. Erickson
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