EDWARDS INTUITY Valve Data Demonstrate Improved Patient Benefits Over Standard Surgical Valves
April 30 2014 - 9:15AM
Marketwired
EDWARDS INTUITY Valve Data Demonstrate Improved Patient Benefits
Over Standard Surgical Valves
TORONTO, ON--(Marketwired - Apr 30, 2014) - 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 functional status.
These new data from the TRITON1 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 the valve."
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
percent 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
www.edwards.com.
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.
Media Contact: Steve Chesterman 949-250-5070 Investor Contact:
David K. Erickson 949-250-6826
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