IRVINE, Calif., June 30, 2014 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
it has received U.S. Food and Drug Administration (FDA) clearance
for the ClearSight system.
To view the multimedia assets associated with this release,
please click:
http://www.multivu.com/players/English/7256451-edwards-fda-clearance-for-noninvasive-hemodynamic-monitoring-system/
The ClearSight system is a noninvasive monitor that provides
clinicians access to valuable blood volume and blood flow
information for patients at moderate or high risk of post-surgical
complications, in whom invasive monitoring would not be used.
Using a cuff on the outside of the finger that is connected to
the Edwards EV1000 clinical platform, the ClearSight system:
- utilizes Edwards' proven, gold-standard monitoring technologies
that are used in hospitals around the world, and incorporates a
finger cuff and software elements that have been used for the
noninvasive monitoring of the blood pressure of astronauts in
space;
- automatically provides up-to-the-minute information without
inserting anything into the body – as compared to the traditionally
more invasive approach to monitoring, which today is only used in a
fraction of those patients at risk of post-surgical complications;
and thus
- provides an opportunity to extend the benefits of hemodynamic
optimization, or proper fluid administration and balance within a
patient's organs and tissues, to a broader patient population that
could benefit from close monitoring, but may not receive it without
a noninvasive option.
"Proper intraoperative management of moderate and high-risk
surgery patients is critical to help reduce the risk of
post-surgical complications," said Julie K.
Thacker, M.D., surgical oncologist at Duke University Hospital. "Studies have indicated
that patient outcomes are improved through monitoring and
management of vital hemodynamic information through hemodynamic
optimization protocols."
"The ClearSight system is the most advanced noninvasive monitor
of its kind. This important development in the field of
critical care medicine builds on Edwards' 40 years of experience in
providing clinicians with tools to make more informed decisions
that can advance patient care by helping to reduce complications,
shorten hospital stays and lower associated costs," said
Carlyn D. Solomon, Edwards'
corporate vice president, critical care and vascular.
The ClearSight system is also available in CE Mark
countries.
About Hemodynamic Monitoring
Hemodynamic monitoring is the measurement of blood circulation
and cardiac function that allows clinicians to evaluate whether
enough oxygen is being delivered to the organs and tissues.
Healthcare providers use this information to detect changes or
problems in a patient's health, which allows for more informed,
immediate treatment decisions.
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.
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 Mr.
Solomon's and Dr. Thacker's statements and statements regarding
design features, expected benefits and procedural outcomes with
the ClearSight system. 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 actual
results to differ materially from those expressed or implied by the
forward-looking statements based on a number of factors including
but not limited to expanded clinical experience, unexpected changes
or delays related to product supply, quality and availability,
changes in product indications or reimbursement levels, or
regulatory decisions. 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, 2013.
Edwards, Edwards Lifesciences, the stylized E logo, ClearSight,
and EV1000 are trademarks of Edwards Lifesciences
Corporation. All other trademarks are the property of their
respective owners.
To view the multimedia assets associated with this release,
please click:
http://www.multivu.com/players/English/7256451-edwards-fda-clearance-for-noninvasive-hemodynamic-monitoring-system/
SOURCE Edwards Lifesciences