PARIS, May 19, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
that the first high-risk European patients to receive the advanced
Edwards SAPIEN 3 transcatheter aortic valve via transfemoral
delivery had a one-year survival rate of 91.6 percent, as well as
low rates of stroke and paravalvular leak. The independently
adjudicated data from the CE Mark study were presented at EuroPCR
2015 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.
Among the outcomes reported from the study, transfemoral SAPIEN
3 transcatheter aortic valve replacement (TAVR) was associated with
a disabling stroke rate of 1.1 percent. In addition, only 2
percent of patients had moderate paravalvular leaks and there were
no reports of severe leaks. There were also no observations
of structural valve deterioration.
"The one-year survival rate in the transfemoral cohort is the
highest reported in a multicenter, fully adjudicated TAVR study to
date. These results set a new standard of care for patients
at high risk for surgical aortic valve replacement. The
results of the SAPIEN 3 trial via the transfemoral approach also
raise the question of whether transcatheter valve replacement
should be considered for approval for all elderly patients with
severe aortic stenosis," said Webb, who served as a principal
investigator in the trial.
The SAPIEN 3 Trial is a prospective, multicenter, non-randomized
study. The one-year analysis documented outcomes of the first
150 patients treated with the SAPIEN 3 valve between Jan. 2013 and Nov.
2013 at 16 centers in Europe and Canada*. Access approaches included
transfemoral (n=96) and transapical/transaortic (n=54), as
determined by the Heart Team. At baseline, the patients in
the alternative access group were significantly sicker than the
transfemoral group. All-cause mortality in the alternative
access group was reported as 24.3 percent in the as-treated
population. The SAPIEN 3 Trial is designed to evaluate
patients annually for five years.
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. 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. Dr. Webb is a consultant to Edwards
Lifesciences.
* 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 statements regarding patient follow-up, design features and
expected product benefits and procedural outcomes of TAVR with 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 actual 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 unexpected outcomes
after more expanded clinical experience and longer term follow-up,
unexpected product supply, regulatory or quality developments, and
changes to trends in customer experience or patient follow-up.
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, eSheath,
PARTNER, PARTNER II, Edwards SAPIEN, SAPIEN and SAPIEN 3 are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation