BALTIMORE, May 17, 2016 /PRNewswire/ -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in patient-focused
innovations for structural heart disease and critical care
monitoring, today announced positive clinical trial results on two
of its advanced innovations in surgical heart valves for the
treatment of people with aortic valve disease. Data from three
studies—COMMENCE, TRANSFORM and FOUNDATION—were presented as part
of the late-breaking sessions at the American Association for
Thoracic Surgery's (AATS) 96th annual meeting.
"Edwards is proud to lead the innovation of heart valve
therapies to address a broad range of patient needs around the
world, and these compelling new data on more than 2,000 patients
provide important clinical evidence on the benefits of new surgical
treatments," said Bernard Zovighian,
Edwards' corporate vice president, surgical heart valve therapy.
"We are committed to expanding our surgical heart valve portfolio
with meaningful innovations and by continuing to work in
partnership with surgeons to meet the needs of patients who suffer
from a variety of heart valve diseases."
COMMENCE Trial Data
Data from 673 patients in the COMMENCE pivotal trial
demonstrated early safety and effectiveness of Edwards' surgical
aortic valve featuring RESILIA tissue, a novel tissue
platform. Beyond delivering strong safety results, the new
valve with RESILIA tissue showed no cases of structural valve
deterioration, valve thrombosis or nonstructural valve dysfunction
at one year.
"The early clinical results with the new valve with RESILIA
tissue in this multicenter, international FDA trial are encouraging
and set a high benchmark for surgical aortic valve replacement,"
said John D. Puskas, M.D., chair of
cardiothoracic surgery at Mount Sinai Beth Israel and director of
surgical coronary revascularization at Mount Sinai Health System,
New York, NY. He is the national
principal investigator of the COMMENCE study. "The RESILIA tissue
has the potential to create a new class of surgical tissue valves
that pre-clinical studies have shown to offer key benefits, such as
significantly reduced calcification and sustained
hemodynamics."
TRANSFORM and FOUNDATION Trial Data
Also at AATS, the TRANSFORM pivotal trial data at one year
showed that the EDWARDS INTUITY valve system, a cutting-edge rapid
deployment system for surgical aortic valve replacement, is safe
and effective and may reduce cross-clamp time and cardiopulmonary
bypass time, compared to times recorded in the Society of Thoracic
Surgeons' (STS) Adult Cardiac Database. This may provide patient
benefits such as decreased mortality and morbidity, less time in an
intensive care unit and reduced total hospital stay. In the study,
839 patients were treated with this device, which is built on the
trusted PERIMOUNT tissue valve platform incorporating innovations
from transcatheter heart valves. It evaluated both the
first-generation EDWARDS INTUITY valve (n=109) and the
second-generation EDWARDS INTUITY Elite valve (n=730).
In addition, the FOUNDATION registry studied the real-world
experience of 493 patients who were treated with the
first-generation EDWARDS INTUITY valve system in Europe, with results demonstrating excellent
safety and effectiveness at one year.
"There is a clinical need for innovative surgical heart valve
therapies to ensure patients receive the appropriate treatment, and
the EDWARDS INTUITY Elite valve system is designed to facilitate
minimally invasive surgery and streamline complex aortic valve
replacements, which is a major advancement," said Walter Randolph Chitwood, Jr., MD., founder of
the East Carolina Heart Institute of East
Carolina University, Greenville,
NC. He is a co-principal investigator of the TRANSFORM
study.
Background
Valves with the investigational RESILIA tissue are being studied
as part of the COMMENCE trial, a global clinical program with three
study groups: aortic, mitral and pulmonary. Data presented at AATS
reported on the aortic arm of the program. The mitral study is
enrolling patients, and the pulmonary study for congenital
patients, including children and young adults, began enrollment in
late 2015.
The second generation EDWARDS INTUITY Elite valve system was
approved for commercial sale in Europe in 2014; it is not available for sale
in the United States.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine,
Calif., is the global leader in patient-focused medical
innovations for structural heart disease, as well as critical care
and surgical monitoring. Driven by a passion to help
patients, the company collaborates with the world's leading
clinicians and researchers to address unmet healthcare needs,
working to improve patient outcomes and enhance lives. For more
information, visit www.edwards.com and follow us on Twitter at
@EdwardsLifesci.
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 by Mr.
Zovighian, Dr. Chitwood, and Dr. Puskas and expectations regarding
the products' potential benefits and risks. 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 results to differ materially from those expressed or
implied by the forward-looking statements based on a number of
factors, including but not limited to, unanticipated outcomes of
longer term clinical experience with the products, or unanticipated
manufacturing, quality or regulatory delays or issues. These and
other additional 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,
2015. These filings, along with important safety information
about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE,
EDWARDS INTUITY, EDWARDS INTUITY Elite, FOUNDATION, PERIMOUNT,
RESILIA and TRANSFORM are trademarks of Edwards Lifesciences
Corporation. All other trademarks are the property of their
respective owners.
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SOURCE Edwards Lifesciences Corporation