EDWARDS INTUITY Elite Valve System Receives CE Mark

EDWARDS INTUITY Elite Valve System Receives CE Mark 
Next-Generation Technology Built on Trusted, Proven Platform Designed
for Enhanced Patient Benefits 
IRVINE, CA -- (Marketwired) -- 04/04/14 --   Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced it has received CE
Mark for the advanced EDWARDS INTUITY Elite valve system. This
next-generation, rapid deployment system facilitates smaller
incisions in surgical aortic valve replacement (AVR) procedures, and
is built upon extensive evidence supporting the durability of the
Carpentier-Edwards PERIMOUNT heart valve design. 
"We're encouraged by the introduction of heart valve technologies
that are developed to facilitate a minimally invasive approach for
the improved treatment of patients with aortic valve disease," said
Prof. Michael Borger, M.D., Ph.D., associate director of the
Department of Cardiac Surgery at the Leipzig Heart Center in Germany.
"Our experience with the EDWARDS INTUITY platform has shown the
ability to implant the valve through smaller incisions, with
significantly reduced cross-clamp time and improved hemodynamics.
This less-invasive, more efficient surgical approach should benefit
patients during and after their procedure." 
The next-generation EDWARDS INTUITY Elite valve system combines a
unique balloon-expandable frame with Edwards' proven pericardial
PERIMOUNT platform, which has demonstrated durability up to 25 years
in published studies. The new system has design improvements intended
to improve ease of use, including a flexible and lower profile
delivery system that is designed to facilitate access and visibility
through smaller incisions.  
"We've enhanced the EDWARDS INTUITY design to further meet the needs
of patients, physicians and hospitals with a valve and procedure that
can be readily incorporated into the surgeon's treatment offerings,"
said Donald E. Bobo, Jr., Edwards' corporate vice president, heart
valve therapy. "We believe the EDWARDS INTUITY platform can greatly
expand the population of patients who receive the less-invasive
approach with important clinical and cost benefits." 
Advanced Innovation for Surgeons and Patients Backed by Robust
Clinical Data
 Data from 100 patients in the CADENCE-MIS trial, a
randomized, controlled, multi-center trial comparing
minimally-invasive AVR with the EDWARDS INTUITY valve system to full
sternotomy AVR with any conventional bioprosthetic aortic valve, were
recently presented at the 2014 Annual Meeting of the Society of
Thoracic Surgeons (STS). The trial found: 


 
--  Minimally-invasive AVR with the EDWARDS INTUITY platform demonstrated
    a statistically significant reduction (24 percent) in ischemic time
    (the amount of time blood flow to and from the heart is stopped during
    surgery) compared to the full sternotomy approach with conventional
    bioprosthetic valves. These results are especially meaningful as
    minimally-invasive approaches have traditionally been associated with
    longer ischemic times; and
--  Improved blood flow and hemodynamics with the EDWARDS INTUITY valve
    compared to conventional bioprosthetic valves at 3-month follow-up.

  
Additionally, an interim analysis of 158 patients undergoing isolated
aortic valve replacement in the prospective, multicenter, single-arm
TRITON Trial(1) for the EDWARDS INTUITY platform, found that 55
percent were performed through a minimally invasive approach, as
opposed to a full sternotomy. 
The EDWARDS INTUITY Elite Valve System is currently being studied as
part of the TRANSFORM Trial, the first U.S. clinical trial of a rapid
deployment system for surgical aortic valve replacement. It is an
investigational device and not yet available for sale or use in the
United States. The system will be commercially available at hospitals
throughout Europe and is supported with favorable reimbursement in
Germany as part of diagnosis-related group (DRG) mapping that
includes the new category of rapid-deployment aortic valve systems. 
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. Borger and Mr. Bobo's
statements and statements regarding the launch and estimated roll-out
of the EDWARDS INTUITY Elite Valve System, design features and
expected product benefits and procedural outcomes. 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
expanded 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, CADENCE, 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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