Excellent Early Experience Reported With Edwards SAPIEN 3 Transcatheter Valve
PARIS, FRANCE -- (Marketwired) -- 05/20/14 -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that the first
data on its most advanced commercially available transcatheter aortic
heart valve, the Edwards SAPIEN 3 valve, were presented in a
late-breaking clinical trial session at EuroPCR 2014 by John Webb,
M.D., director of interventional cardiology and cardiac
catheterization laboratories at St. Paul's Hospital, Vancouver, and
professor of cardiology at the University of British Columbia.
The presentation concluded that outcomes at 30 days were excellent.
Transfemoral SAPIEN 3 implantation was associated with a very low
mortality of 2.1 percent, a stroke rate of 1.0 percent, and very few
access-site complications. In addition, 96.6 percent of patients had
≤ mild paravalvular leak. There was no severe paravalvular
"These data demonstrated that the improved valve and delivery system
design allowed precise positioning of the SAPIEN 3 valve, and early
outcomes from the trial clearly demonstrated outstanding safety. The
results of this study indicate the SAPIEN 3 valve may enable
treatment of intermediate-risk patients with aortic stenosis," said
Webb, who served as a principal investigator in the trial and is a
consultant to Edwards Lifesciences.
The SAPIEN 3 Trial is a prospective, multicenter, non-randomized
study. This analysis documented early outcomes of the first 150 high-and intermediate-risk patients enrolled between Jan. 2013 and Nov.
2013 and treated with the SAPIEN 3 valve at 16 centers in Europe and
Canada*. Access approaches included transfemoral (n=96) and
transapical/transaortic (n=54), as determined by the Heart Team.
All-cause mortality in all access approaches was reported as 5.3
percent in the as-treated population. The company intends for
patients to be followed annually out to five years.
"The Edwards SAPIEN 3 valve sets a new standard for tissue valves,
combining a low-profile design with the ability to address
paravalvular leak, as well as improved delivery systems," said Larry
L. Wood, corporate vice president, transcatheter heart valves. "It is
particularly encouraging that these early results showed that none of
the patients were re-hospitalized during the follow-up period, which
is a meaningful outcome for patients who had previously been very
The SAPIEN 3 valve can be delivered through a low-profile 14 French
expandable sheath (eSheath). It also has an outer skirt -- a cuff of
fabric that provides a seal at the bottom of the frame that is
designed to reduce paravalvular aortic regurgitation.
The SAPIEN 3 valve was approved in Europe in January 2014 for the
treatment of high-risk and non-operable patients with severe aortic
stenosis. It is not approved for the treatment of intermediate risk
patients in Europe. The valve is an investigational device not yet
available commercially in the United States. It is currently being
evaluated in the U.S. in The PARTNER II Trial.
All percents cited in the press release are Kaplan-Meier estimates.
* Enrollment centers are in Canada, France, Germany, Italy and United
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. Webb
and Mr. Wood and statements regarding patient follow-up, design
features and expected product benefits and procedural outcomes of the
Edwards SAPIEN 3 valve. 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 and
longer term follow-up, unexpected changes or delays related to
product supply orregulatory or quality developments, and trends in
customer experience. 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, eSheath, PARTNER,
PARTNER II, SAPIEN and SAPIEN 3 are trademarks of Edwards
Lifesciences Corporation. All other trademarks are the property of
their respective owners.
David K. Erickson
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