IRVINE, Calif., Aug. 15, 2016 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced U.S. Food and Drug
Administration approval of the advanced EDWARDS INTUITY Elite valve
system, a rapid deployment device for surgical aortic valve
replacement. Built on the trusted PERIMOUNT tissue valve platform
and incorporating innovations from transcatheter heart valves, the
EDWARDS INTUITY Elite valve system is designed to facilitate
minimally invasive surgery and streamline complex aortic valve
replacements, thereby offering a cutting-edge treatment option for
patients with aortic valve disease. The device is now commercially
available.
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"Many patients with aortic stenosis have more than one type of
heart disease, most commonly coronary artery disease. The EDWARDS
INTUITY Elite valve system enables surgeons to streamline
concomitant procedures, which can be beneficial for patients
undergoing these longer, more complex surgeries," said Kevin Accola, M.D., program director, Valve
Center for Excellence at the Florida Hospital Cardiovascular
Institute in Orlando, Fla.
Mubashir A. Mumtaz, M.D.,
F.A.C.S., F.A.C.C., chief of cardiothoracic surgery and surgical
director of the structural heart program at PinnacleHealth in
Harrisburg, Pa., said, "Patients
request less invasive surgical options, and the EDWARDS INTUITY
Elite valve system meets this need by facilitating multiple
approaches to minimally invasive operations, which can mean less
trauma, early recovery and decreased need for blood transfusions
for many patients."
FDA approval of the EDWARDS INTUITY Elite valve system was
supported by data from the TRANSFORM clinical trial, which treated
839 patients in 29 centers in the U.S. The results of this trial
were presented recently during a late-breaking session at the
American Association for Thoracic Surgery's (AATS) 96th
annual meeting. The data showed that, at one year, the EDWARDS
INTUITY valve system 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. Overall, the New York Heart
Association (NYHA) Functional Classification, which categorizes
patients into one of four groups based on their heart failure
symptoms and physical limitations, improved in 73.1 percent of
patients at one year.
"U.S. approval of the EDWARDS INTUITY Elite valve system is a
significant milestone as this technology provides an
advanced surgical treatment option for patients suffering from
aortic valve disease," said Bernard
Zovighian, Edwards' corporate vice president, surgical heart
valve therapy. "In partnership with surgeons, Edwards is committed
to developing more innovative surgical technologies, like the
EDWARDS INTUITY Elite valve system, in order to address patient
needs."
The device was approved for commercial sale in Europe in 2014.
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. Accola and Dr. Mumtaz and expectations regarding the
products' potential benefits and risks, as well as expected future
innovations. 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, development 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
www.edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS
INTUITY, EDWARDS INTUITY Elite, PERIMOUNT 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