SAN DIEGO, March 15, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
that the final five-year clinical data for high-risk patients
treated with the first-generation SAPIEN transcatheter aortic valve
in The PARTNER Trial demonstrated equivalent outcomes to
traditional open-heart surgery, and no structural valve
deterioration requiring intervention. Data from the world's
first prospective randomized trial for transcatheter aortic valve
replacement (TAVR) in patients at high risk for surgery were
presented as part of the late-breaking clinical trials at the
American College of Cardiology's (ACC) 64th Annual
Scientific Session in San Diego,
and simultaneously published in The Lancet.
"It's remarkable that this five-year data report continues to
show equivalency between what was then a brand new procedure with a
first-generation TAVR device and the gold standard of surgery,
which has been honed over 50 years of experience," said
Michael J. Mack, M.D., chair,
cardiovascular service line, Baylor
Scott & White Health. "Just as we observed in the
five-year report from The PARTNER Trial on outcomes in inoperable
patients treated with SAPIEN, the high-risk patients also had
durable valve performance. These data show that TAVR is an
effective treatment for these patients."
The authors noted no significant differences in all-cause
mortality, cardiovascular mortality, stroke or need for repeat
hospitalization.
The high-risk surgery cohort (Cohort A) of The PARTNER Trial
enrolled between May 2007 and
Sept. 2009 and studied 699 patients
with severe, symptomatic aortic stenosis deemed at high risk for
traditional open-heart surgery. Patients were evaluated by a
multi-disciplinary Heart Team and randomized to receive either
traditional open-heart surgery or the Edwards SAPIEN valve with
transfemoral or transapical delivery. This trial represented
the initial TAVR experience for most trial sites in the United States.
The U.S. Food and Drug Administration (FDA) approved the SAPIEN
valve in November 2011 for the
treatment of inoperable patients, and expanded the indication to
high-risk surgical patients in October 2012. In June 2014, the FDA approved the next-generation
SAPIEN XT valve for the treatment of both inoperable and high-risk
patients. The Edwards SAPIEN family of valves are the most
studied transcatheter heart valves in history and have been used in
the treatment of more than 100,000 patients globally. A second
data presentation during the ACC late-breaking clinical trials
detailed outcomes with the investigational SAPIEN 3 valve, which is
summarized in a separate press release.
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
edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN XT, SAPIEN, SAPIEN XT and PARTNER are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation