IRVINE, Calif.,
July 5, 2017 /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 U.S. Food
and Drug Administration (FDA) approval for its INSPIRIS RESILIA
aortic valve, the first in a new class of resilient heart
valves.
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"The INSPIRIS valve sets a new benchmark for surgical
aortic valve replacement, providing patients, particularly those
with active lifestyles, with a resilient tissue valve that is built
on Edwards' legacy of excellence in heart valve innovations,"
said John D. Puskas,
MD, MSc, FACC, FACS, professor of Cardiothoracic Surgery, Icahn
School of Medicine at Mount Sinai, chairman, Department of
Cardiothoracic Surgery, Mount Sinai Saint Luke's, Mount Sinai Beth
Israel and Mount Sinai West (Roosevelt) and national
principal investigator of the COMMENCE pivotal trial, an FDA
premarket approval study.
Joseph Bavaria, MD, Roberts-Measey professor and vice
chief of cardiovascular surgery at the University of Pennsylvania and the top implanter in
the COMMENCE pivotal trial, said, "With the addition of VFit
technology, featuring the unique expandable design feature, the
INSPIRIS valve provides an ideal foundation for heart valve
patients, both now and in the future."
The INSPIRIS valve features three differentiating
elements:
- RESILIA tissue, a breakthrough tissue
technology that delivers the combination of enhanced
anti-calcification properties, improved sustained hemodynamic
performance and dry storage;
- A first-of-its-kind expandable frame, VFit
technology also incorporates fluoroscopically visible
size markers and is designed for potential future valve-in-valve
procedures;
- A trusted valve platform built on the proven
performance of the Carpentier-Edwards PERIMOUNT valve
design, which has more than 20 years of published clinical
durability.
Approval of the INSPIRIS valve is supported by the
COMMENCE pivotal trial. Published in the European Journal of
Cardio-Thoracic Surgery, two-year data of 689 patients from the
COMMENCE trial showed no cases of structural
valve deterioration, valve thrombosis or nonstructural valve
dysfunction. In addition, the European RESILIA tissue feasibility
study, which initiated enrollment in 2011, underscores the safety
and effectiveness of the RESILIA tissue. Four-year results from the
European feasibility study will be presented at the 31st European
Association for Cardio-Thoracic Surgery's (EACTS) annual meeting in
October.
"Building on Edwards' 40 years of leadership
in tissue valve technology, the INSPIRIS valve
featuring RESILIA tissue has been in development for more than a
decade and may be uniquely suited for future valve-in-valve
procedures," said Bernard
Zovighian, Edwards' corporate vice president, surgical heart
valve therapy. "In partnership with surgeons, Edwards is committed
to continually developing transformative surgical innovations that
benefit patients."
Plans are underway for a full U.S. launch of the INSPIRIS
valve in early 2018. The valve became commercially
available in Europe earlier this
year.
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 Drs. Puskas and Bavaria 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
expanded and longer term clinical experience with the product, 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, 2016. These
filings, along with important safety information about our
products, may be found at www.edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo,
Carpentier-Edwards, COMMENCE, INSPIRIS, INSPIRIS RESILIA,
PERIMOUNT, RESILIA, and VFit are trademarks of Edwards Lifesciences
Corporation. All other trademarks are the property of their
respective owners.
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SOURCE Edwards Lifesciences Corporation