IRVINE, California,
Sept. 29, 2016 /PRNewswire/
-- Edwards Lifesciences Corporation (NYSE: EW), the global
leader in patient-focused innovations for structural heart disease
and critical care monitoring, today announced it received CE Mark
for its INSPIRIS RESILIA aortic valve, the first in a new class of
resilient heart valves. Incorporating the advanced RESILIA tissue,
the INSPIRIS valve leverages features of the trusted PERIMOUNT
Magna Ease valve and includes the proprietary VFit technology,
which is designed for potential future valve-in-valve
procedures.
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"Heart valve patients are living longer and want to maintain
their active lifestyles. The INSPIRIS valve provides surgeons and
their patients with an advanced treatment option that represents an
ideal foundation for the future treatment of heart valve patients,"
said Vinayak (Vinnie) Bapat, MBBS,
MS, FRCS, FRCS.CTh, consultant cardiothoracic surgeon at Guy's and
St. Thomas' Hospital in London.
Bernard Zovighian, Edwards'
corporate vice president, surgical heart valve therapy, said, "The
INSPIRIS valve creates a new class of surgical valves and includes
key patient-focused innovations, such as the resilient tissue and
the VFit technology, to advance the treatment of patients with
heart valve disease. In partnership with surgeons, Edwards is
committed to developing differentiating technologies that set a new
standard for surgical heart valves."
A key innovation of the INSPIRIS valve is RESILIA tissue, a new,
first-of-its-kind tissue platform that has been in development for
more than a decade and builds on Edwards' 40 years of leadership in
tissue technology. RESILIA tissue utilizes Edwards' integrity
preservation technology, which preserves the tissue and provides
improved anti-calcification properties and sustained hemodynamic
performance. In addition, the valve is stored dry and ready to use.
CE Mark of the INSPIRIS valve was supported by the COMMENCE
pivotal trial, a global, U.S. Food and Drug Administration
premarket approval study. One-year results of this study were
presented during this year's late-breaking sessions at the American
Association for Thoracic Surgery's (AATS) 96th annual
meeting. The results of 673 patients showed no cases of structural
valve deterioration, valve thrombosis or nonstructural valve
dysfunction. In addition, a series of pre-clinical studies have
shown RESILIA tissue to offer key benefits, such as significantly
reduced calcification and sustained hemodynamics compared to a
current treatment option.
Additional data from the COMMENCE trial will be presented
Oct. 3 during a late-breaking session
at the 30th European Association for Cardio-Thoracic
Surgery's (EACTS) annual meeting. In addition, three-year results
of the RESILIA tissue EU feasibility study will be presented during
EACTS Oct. 2.
The INSPIRIS valve is planned for a targeted commercial release
in Europe in Q4 of 2016 and a full
launch in Q1 of 2017. The VFit feature is available in sizes 19mm
through 25mm. It is not approved for commercial use in the U.S.
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
@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 Dr. Bapat
and Mr. Zovighian and expectations regarding the product's
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
broader and 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, COMMENCE,
INSPIRIS, INSPIRIS RESILIA, Magna, Magna Ease, PERIMOUNT, PERIMOUNT
Magna, PERIMOUNT Magna Ease, RESILIA, and VFit are trademarks of
Edwards Lifesciences Corporation. All other trademarks are the
property of their respective owners.