IRVINE, Calif., June 16, 2014 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
that it has received United States Food and Drug Administration
(FDA) approval for its Edwards SAPIEN XT transcatheter aortic heart
valve for the treatment of high-risk and inoperable patients
suffering from severe symptomatic aortic stenosis (AS). This
next-generation, lower-profile system, which includes the 29mm
valve size for patients with a large native annulus, will allow for
the treatment of more patients.
The Edwards SAPIEN XT valve will be immediately available to
patients at leading cardiovascular centers across the nation, along
with the NovaFlex+ transfemoral delivery system that can be
delivered through a low-profile 16-French expandable sheath
(eSheath) and the Ascendra+ transapical and transaortic delivery
systems.
"There is a substantial and growing body of evidence that the
SAPIEN XT valve benefits both high-risk and inoperable patients,
and clinicians have documented these consistently positive results
in both randomized studies and European country registries," said
Martin B. Leon, MD, director, Center
for Interventional Vascular Therapy at
NewYork-Presbyterian/Columbia
University Medical Center and professor of medicine at
the Columbia University College of
Physicians and Surgeons. Dr. Leon was the co-principal
investigator for the PARTNER II Trial, which was Edwards' second
randomized controlled trial of a transcatheter valve and evaluated
the SAPIEN XT valve. "The results from the PARTNER II Trial in
treating U.S. inoperable patients with the SAPIEN XT valve
demonstrated a reduction in complications with the TAVR procedure,
and improved patient outcomes over earlier trials."
"Clinicians have demonstrated their confidence in the SAPIEN
valves by making them the market-leading transcatheter valves, and
this approval provides greater options for U.S. patients who can
benefit from the substantial enhancements in this proven platform,"
said Larry L. Wood, Edwards'
corporate vice president, transcatheter heart valves. "The
SAPIEN family of valves has been used in the treatment of more than
70,000 patients globally – with the majority of those patients
treated with SAPIEN XT – and we look forward to Heart Teams across
America transforming the lives of even more patients with this
advanced transcatheter valve."
The Edwards SAPIEN XT valve has been commercially available in
Europe since 2010, and received
regulatory and reimbursement approval in Japan in 2013.
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.
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 of Dr. Leon and Mr. Wood and statements regarding the
launch status, availability and benefits of SAPIEN XT.
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 delays in the
timing or scale of launch, or unexpected clinical outcomes
following the U.S. launch, regulatory actions, competitive
activity, or quality or manufacturing issues. 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, Ascendra+,
Novaflex+, eSheath, PARTNER II, SAPIEN and SAPIEN XT are trademarks
of Edwards Lifesciences Corporation. All other trademarks are
the property of their respective owners.
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SOURCE Edwards Lifesciences