IRVINE, Calif., Oct. 15, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
it has received U.S. Food and Drug Administration (FDA) approval
for aortic valve-in-valve procedures using the Edwards SAPIEN XT
transcatheter heart valve.
"U.S. approval of the valve-in-valve procedure provides an
important minimally invasive treatment option for patients who are
at high risk for a subsequent open-heart surgery to replace their
bioprosthetic valves," said Larry L.
Wood, Edwards' corporate vice president, transcatheter heart
valves.
Today, at the 27th Transcatheter Cardiovascular
Therapeutics (TCT), the annual scientific symposium of the
Cardiovascular Research Foundation, in San Francisco, one-year patient outcomes were
presented for patients treated with transcatheter SAPIEN XT valve
implantation in surgical tissue valves. The valve-in-valve
procedure was associated with a high overall one-year survival rate
of 86.6 percent and a low overall stroke rate of 3.7 percent in a
very high-risk patient population, according to independently
adjudicated data from the 197-patient PARTNER II Valve-in-Valve
study. The study, which is a multicenter, non-randomized cohort of
The PARTNER II Trial, included 97 patients enrolled in the primary
registry as well as 100 continued access patients.
"We were very pleased to see 100 percent survival at 30 days
with the 100 high-risk patients treated with the SAPIEN XT
valve-in-valve procedure in the continued access registry," said
Danny Dvir, M.D., interventional
cardiologist at the Center for Heart Valve Innovation at
St. Paul's Hospital, Vancouver, who presented the data. "This is
quite remarkable and supports transcatheter aortic valve-in-valve
replacement with the SAPIEN XT valve as a safe therapeutic
alternative to reoperation for patients in need of a subsequent
tissue valve replacement."
The Edwards SAPIEN XT valve was approved by the FDA in
June 2014 for patients at high risk
for native aortic valve replacement surgery, and received CE Mark
for valve-in-valve procedures in early 2014. The SAPIEN valve
platform has been used in the treatment of more than 100,000
patients worldwide.
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 made by Mr. Wood and Dr. Dvir and statements regarding
the potential need for, and features and benefits of, the use of
SAPIEN XT for valve-in-valve procedures. 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
following longer term clinical experience; unexpected changes
related to product supply; potentials for unexpected regulatory or
quality developments; and changes in competitive dynamics, global
economic conditions or customer acceptance. 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, 2014. 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
SAPIEN, Edwards SAPIEN XT, PARTNER, 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 Corporation