Edwards SAPIEN Transcatheter Heart Valve Demonstrates Substantial Improvement in Quality of Life in Inoperable PatientsBy Edwards Lifesciences Corporation, PRNE
Monday, November 15, 2010
IRVINE, California, November 16, 2010 - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, announced that in
addition to the improved survival seen in inoperable aortic stenosis patients
treated with the Edwards SAPIEN transcatheter heart valve in The PARTNER
Trial, a newly released analysis of the same patients shows that they also
experienced substantially better quality of life. These results were
presented at the American Heart Association's Scientific Sessions 2010.
To view the Multimedia News Release, please click:
"The degree and immediacy of the quality of life improvement was
striking, with significant benefits seen as early as one month. By one year,
patients experienced both cardiovascular and physical health benefits, with
the physical improvements roughly comparable to a 10-year reduction in age,"
said David J. Cohen, M.D., M.Sc., Director of Cardiovascular Research at St.
Luke's Mid America Heart and Vascular Institute, and principal investigator
for the quality of life sub-study that was funded by Edwards. "Quality of
life is critically important, particularly for patients like those in this
trial — and they are not just surviving, but also thriving."
The 358 patients were assessed upon enrollment in The PARTNER Trial, and
at follow-up intervals of one month, six months and 12 months, on a broad
range of factors, such as their symptoms, physical and social limitations,
and heart-failure related quality of life. Several scientifically validated
surveys were used to collect information from the patient's own perspective,
including the Kansas City Cardiomyopathy Questionnaire (KCCQ), the SF-12
Health Status Survey and the EQ-5D (EuroQOL).
On a scale from 0 to 100, where a 20-point improvement is considered
substantial, the Edwards transcatheter valve patients had a 25-point
improvement in quality of life scores compared to the control group at one
year, using the KCCQ instrument. Similarly positive results were demonstrated
for the other two surveys.
The PARTNER Trial is the first randomized, controlled pivotal trial of a
transcatheter aortic heart valve. The Edwards SAPIEN transcatheter valve is
an investigational device in the United States.
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 that enable them to
save and enhance lives. Additional company information can be found at
Edwards is a trademark of Edwards Lifesciences Corporation. Edwards
Lifesciences, the stylized E logo and Edwards SAPIEN are trademarks of
Edwards Lifesciences Corporation and are registered in the United States
Patent and Trademark Office.
Michael George, +41(22)7874304, Michael_George at edwards.com
Tags: california, Edwards Lifesciences Corporation, Irvine, November 16