EDWARDS INTUITY Elite Valve System Receives CE Mark
April 04 2014 - 3:00AM
Marketwired
EDWARDS INTUITY Elite Valve System Receives CE Mark
Next-Generation Technology Built on Trusted, Proven Platform
Designed for Enhanced Patient Benefits
IRVINE, CA--(Marketwired - Apr 4, 2014) - 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 Trial1 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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