WASHINGTON, Nov. 1, 2016 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced new data demonstrating
dramatic and sustained improvements in quality of life for severe
aortic stenosis (AS) patients at intermediate surgical risk treated
with Edwards transcatheter heart valves. Study results were
presented at the 28th Transcatheter Cardiovascular
Therapeutics (TCT), the annual scientific symposium of the
Cardiovascular Research Foundation, in Washington, D.C.
The new data, involving more than 3,000 patients enrolled in The
PARTNER II Trial, showed dramatic improvements in cardiovascular
health status as well as overall physical and mental well-being
after transcatheter aortic valve replacement, or TAVR, with the
Edwards SAPIEN XT and SAPIEN 3 valves. The health benefits with
TAVR were early and sustained.
"Because AS patients are generally elderly and often have
multiple comorbid conditions, many of them care more about
maintaining or improving their quality of life rather than simply
achieving a longer life," said David J.
Cohen, M.D., Professor of Medicine at the University of Missouri-Kansas City and Director of
Cardiovascular Research at Saint Luke's Mid America Heart
Institute, who presented the late-breaking data from the PARTNER II
randomized trial at TCT. "Taken together with previous data
demonstrating very low mortality and disabling stroke rates with
transfemoral TAVR among patients at intermediate surgical risk,
these findings demonstrate that, for such patients, TAVR
provides both early and late benefits that are important from the
patient's perspective."
In the quality-of-life study performed alongside the PARTNER II
Trial comparing TAVR with surgical aortic valve replacement,
patients treated via transfemoral TAVR with the SAPIEN XT valve saw
substantially greater health status improvements at one month than
patients treated with surgery. Overall, 71.1 percent of patients
treated with transfemoral TAVR experienced health status
improvements at one month compared with just 44.7 percent of
patients treated surgically. Moreover, when mortality and the
extent of quality of life improvement were evaluated together,
transfemoral TAVR with the SAPIEN XT valve was superior to surgery
at the 1- and 2-year follow-up, as well. In the transthoracic
cohorts, mortality and quality of life benefits were similar to
surgery.
Building off the foundational work of the PARTNER II randomized
trial, a separate analysis of intermediate-risk patients treated
with the SAPIEN 3 valve in the PARTNER II Trial demonstrated even
greater health status improvements than the SAPIEN XT valve at one
month with persistent benefits compared with surgery at one year.
These data were presented by Suzanne J.
Baron, M.D., M.Sc., Assistant Professor of Medicine at the
University of Missouri-Kansas City and
a Clinical Scholar at Saint Luke's Mid America Heart Institute.
The SAPIEN XT and SAPIEN 3 valves are the only transcatheter
aortic valves approved for the treatment of intermediate-risk
patients in the United States.
Cohen is a consultant to Edwards Lifesciences.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine,
Calif., is the global leader in patient-focused medical
innovations for structural heart disease, as well as critical care
and surgical monitoring. Driven by a passion to help patients, the
company collaborates with the world's leading clinicians and
researchers to address unmet healthcare needs, working to improve
patient outcomes and enhance lives. For more information, visit
www.Edwards.com and follow us on Twitter @EdwardsLifesci.
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. Cohen
and statements regarding expected product benefits and procedural
outcomes. 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, or
unexpected changes or delays related to product manufacturing or
clinical practice. 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, 2015. Our filings, along with
important product safety information, are available at
www.Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN XT, Edwards SAPIEN 3, PARTNER, PARTNER II,
SAPIEN, SAPIEN XT, and SAPIEN 3 are trademarks of Edwards
Lifesciences Corporation. All other trademarks are the property of
their respective owners.
Logo - http://photos.prnewswire.com/prnh/20140714/126903
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/early-and-sustained-quality-of-life-improvements-seen-for-intermediate-risk-patients-treated-with-edwards-transcatheter-valves-300354706.html
SOURCE Edwards Lifesciences Corporation