Excellent Early Experience Reported With Edwards SAPIEN 3 Transcatheter Valve
May 20 2014 - 8:10AM
Marketwired
Excellent Early Experience Reported With Edwards SAPIEN 3
Transcatheter Valve
PARIS, FRANCE--(Marketwired - May 20, 2014) - 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 leak.
"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 ill."
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 Kingdom.
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.
Media Contact: Sarah Huoh 949-250-5070
Investor Contact: David K. Erickson 949-250-6826
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