WASHINGTON, Sept. 13, 2014 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
the presentation of five-year clinical outcomes for inoperable
patients treated in The PARTNER Trial, the world's only prospective
randomized trial for transcatheter aortic valve replacement (TAVR)
in patients deemed too sick for open-heart surgery. The data were
presented as part of the late-breaking clinical trials session at
the 26th Transcatheter Cardiovascular Therapeutics
(TCT), the annual scientific symposium of the Cardiovascular
Research Foundation.
"These longer term results from PARTNER's inoperable cohort
indicated that TAVR was associated with a continued significant
mortality benefit, persistent symptom benefit and a statistically
significant reduction in rehospitalizations," said Michael J. Mack, M.D., chair, cardiovascular
service line, Baylor Scott &
White Health. "It is reassuring now five years later that in this
very ill and elderly patient group facing a high likelihood of
mortality, more patients treated with SAPIEN experienced sustained
improvements in functional heart status and fewer repeat
hospitalizations – two measures that signify an improvement in
quality of life.
"This was the first study of its kind for transcatheter heart
valves," said Mack. "The PARTNER Trial has historical
significance in the development of TAVR and continues to provide
the clinical community with important information about the
durability and performance of the Edwards SAPIEN valves."
The Edwards family of SAPIEN valves are the most studied
transcatheter heart valves in history and have been used in the
treatment of more than 85,000 patients globally.
The prospective, multicenter PARTNER Trial provided the initial
experience with transcatheter aortic valve replacement in
the United States. The trial
documented the outcomes of 358 inoperable aortic stenosis (AS)
patients treated at 21 centers between 2007 and 2009. In
Cohort B of The PARTNER Trial, inoperable patients with severe,
symptomatic AS were evenly randomized to receive either
transfemoral TAVR with the SAPIEN valve or standard therapy, which
included balloon aortic valvuloplasty or medical management of
symptoms. The one- and two-year results from The PARTNER
Trial were published in The New England Journal of Medicine.
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.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, SAPIEN 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