IRVINE, Calif., June 17, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
U.S. Food and Drug Administration (FDA) approval of its most
advanced transcatheter aortic heart valve – the Edwards SAPIEN 3
valve with the Commander Delivery System – for the treatment of
high-risk patients suffering from severe, symptomatic aortic
stenosis.
"The SAPIEN 3 valve sets a new standard for transcatheter heart
valve performance and patient outcomes," said Martin B. Leon, MD, director of the 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. "We have seen some of the best results to date
from the PARTNER II Trial in treating high-risk patients with the
SAPIEN 3 valve. The PARTNER II study concluded that this new valve
reduced several complications associated with the TAVR procedure
such as paravalvular leakage and stroke, and represented a
meaningful improvement over data from prior studies with
earlier-generation devices," Leon said.
Dr. Leon was the co-principal investigator for the PARTNER II
Trial. SAPIEN 3 approval was based on a cohort of the PARTNER II
Trial, which enrolled 583 high-risk patients at 29 U.S. sites.
The SAPIEN 3 valve builds on Edwards' decades of experience in
the development of tissue heart valves, and the proven benefits of
the Edwards SAPIEN valves. The new valve, available in 20mm, 23mm,
26mm and 29mm sizes, has an outer skirt – a cuff of fabric
surrounding the valve frame – providing a seal to address
paravalvular leak.
"U.S. physicians have been eagerly awaiting the launch of the
Edwards SAPIEN 3 valve since it became available in Europe last year, and we appreciate the FDA's
timely and thoughtful review in making this device available to
American patients," said Larry L.
Wood, Edwards' corporate vice president, transcatheter heart
valves. "Based on extensive research and high quality clinical
data, we believe the SAPIEN 3 valve has the potential to transform
patient care in the U.S."
Given the earlier-than-anticipated FDA approval of SAPIEN 3, the
company is ramping up supply and expects the launch to be largely
completed by the end of the year.
The SAPIEN 3 valve has been commercially available in
Europe since January 2014. The SAPIEN family of valves has
been used in the treatment of more than 100,000 patients
globally.
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 by Dr. Leon and Mr. Wood and statements regarding the
expected launch of the Edwards SAPIEN 3 valve, design features and
expected product benefits and procedural outcomes.
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 the roll-out and benefits of the technology to differ
materially from those expressed or implied by the forward-looking
statements based on a number of factors including but not limited
to unexpected outcomes after more expanded clinical experience,
unexpected changes or delays related to product supply, potentials
for unexpected regulatory or quality developments, competitive
dynamics, global economic conditions and 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.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, SAPIEN 3, eSheath, and PARTNER II are trademarks of Edwards
Lifesciences Corporation.
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SOURCE Edwards Lifesciences Corporation