PARIS, May 20, 2015 /PRNewswire/ -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that 30-day
outcomes for intermediate-risk patients treated transfemorally with
the SAPIEN 3 transcatheter aortic valve at centers in Europe and Canada demonstrated very low mortality and
stroke rates, and no severe paravalvular leaks. These
independently adjudicated data are consistent with the outcomes
recently reported in a similar study of 1,000 patients treated at
51 centers in the United States.
The study was presented at EuroPCR 2015 by Alec Vahanian, MD, chair of the cardiology
department at Bichat University Hospital, Paris.
In the multi-center study of 101 intermediate-risk patients,
all-cause mortality was 1 percent. The frequency of other
important complications was also low: the disabling stroke rate was
2 percent, major vascular complications were 2 percent and the
permanent pacemaker rate was 4 percent. The investigators
also noted that the SAPIEN 3 valve had excellent hemodynamic
performance, with very low incidence of significant paravalvular
regurgitation, as only 2.3 percent of patients had moderate
paravalvular leaks and there were no reports of severe
leaks.
"Intermediate-risk patients treated with the Edwards SAPIEN 3
valve had remarkably low mortality at 30 days. There were
very low rates of all other major complications, notably major
vascular complications and new permanent pacemaker implantation,"
said Vahanian. "These results are meaningful since this study
in multiple countries repeated the results in the large U.S.
study."
The SAPIEN 3 Trial is a prospective, multicenter, non-randomized
study. This analysis was designed to document the 30-day
outcomes of intermediate-risk patients treated via the transfemoral
approach with the SAPIEN 3 valve at 13 centers in Europe and Canada*. The SAPIEN 3 Trial is designed
to evaluate patients annually for five years.
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 any country.
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. Prof. Vahanian 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 Prof.
Vahanian and statements regarding patient follow-up 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 in intermediate risk
patients and longer term follow-up, unexpected developments in
product supply, regulatory status or quality developments, and
trends in clinical 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, 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