DENVER, Oct. 31, 2017 /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
substantial economic advantages of the Edwards SAPIEN 3
transcatheter aortic heart valve for patients suffering from
severe, symptomatic aortic stenosis (AS) who are at intermediate
risk for open-heart surgery. Results of the economic analysis,
which is the first-of-its-kind report on intermediate-risk
patients, were presented as a late-breaking clinical trial at the
29th Transcatheter Cardiovascular Therapeutics (TCT),
the annual scientific symposium of the Cardiovascular Research
Foundation, in Denver.
The economic analysis of the SAPIEN 3 valve compared to surgery
involved more than 2,000 patients enrolled in both the PARTNER II A
Trial and the SAPIEN 3 intermediate risk trial. The analysis showed
significantly lower total one-year costs, on average, with the
SAPIEN 3 valve compared with surgical aortic valve replacement
($80,977 vs. $96,489). Average index hospitalization costs,
which include the costs of the procedure, hospital stay and
physician fees, were also lower with the SAPIEN 3 valve versus
surgery ($54,256 vs. $58,410). Reduced length of stay, simpler, more
efficient procedures, fewer repeat hospitalizations, and less time
in rehabilitation contributed to the economically dominant results
of the SAPIEN 3 valve. Transcatheter aortic valve replacement
(TAVR) with the SAPIEN 3 valve added 0.27 quality-adjusted life
years (QALY) per patient at a lifetime cost savings of
approximately $10,000 compared with
surgery. The SAPIEN 3 intermediate risk trial enrolled patients
during 2014.
"Based on both clinical and economic considerations, these
findings demonstrate that TAVR should be the preferred strategy for
patients with severe aortic stenosis at intermediate surgical
risk," 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 study results.
"Taken together with previous data demonstrating excellent clinical
outcomes and significantly improved quality of life with TAVR, this
latest study shows that TAVR with the SAPIEN 3 valve also provides
important short and long-term economic advantages compared with
surgery."
The researchers also performed an analysis of the SAPIEN XT
valve compared with surgery, using data from the randomized PARTNER
II A Trial on 1,938 patients enrolled from 2011 to 2013. According
to the researchers, over a lifetime, TAVR with the SAPIEN XT valve
was also projected to be an economically dominant strategy,
providing both greater quality-adjusted life expectancy and lower
long-term costs than surgery, with a high degree of confidence. The
SAPIEN XT valve is no longer utilized in clinical practice in
the United States; instead, the
next generation SAPIEN 3 valve is utilized in the U.S. and most
other geographies worldwide.
The Edwards SAPIEN 3 valve was approved by the FDA in 2015 for
severe, symptomatic aortic stenosis patients at high risk for
open-heart surgery, and, in 2016, received approval for the
treatment of patients who are at intermediate risk for open-heart
surgery. The SAPIEN 3 valve builds on Edwards' decades of
experience in the development of tissue heart valves, and the
proven benefits of the Edwards SAPIEN valves.
Dr. Cohen is a consultant to Edwards Lifesciences. The
PARTNER II Trial was sponsored by 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 future
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 longer-term 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, 2016. 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.
View original content with
multimedia:http://www.prnewswire.com/news-releases/edwards-sapien-3-transcatheter-valve-demonstrates-significant-cost-savings-over-surgery-in-intermediate-risk-patients-300546173.html
SOURCE Edwards Lifesciences Corporation