Edwards Lifesciences Launching SAPIEN XT Valve In The U.S.
FDA Approval Includes High-Risk and Inoperable Indications, Transfemoral and
Alternative Access Systems
IRVINE, Calif., June 16, 2014
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.
Edwards SAPIEN XT valve
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 Centerand 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
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
Photo - http://photos.prnewswire.com/prnh/20140616/118692
SOURCE Edwards Lifesciences
Contact: Media, Sarah Huoh, +1-949-250-5070, or Investors, David K. Erickson,
+1-949-250-6826, both of Edwards Lifesciences Corporation
Press spacebar to pause and continue. Press esc to stop.