MILAN, Oct. 3, 2016 /PRNewswire/ -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in patient-focused
innovations for structural heart disease and critical care
monitoring, today announced it received CE Mark for its Acumen
Hypotension Probability Indicator (HPI), a breakthrough technology
that alerts clinicians to potential hypotension, or abnormally low
blood pressure, in their surgical and critical care patients before
it occurs. HPI is only compatible with Edwards' minimally invasive,
hemodynamic monitoring solutions.
"Studies have shown that even short durations of hypotension can
be harmful to patients," said Monty
Mythen, the Smiths Medical Professor of Anaesthesia and
Critical Care at University College London. "A first-of-its-kind
technology that enables clinicians to detect and address
potentially developing hypotensive events is a major advance in
patient care."
HPI comprises three elements:
- The hypotension probability parameter, which indicates the
possibility of a hypotensive event using machine learning
techniques developed from more than 20,000 past patient
events;
- An alarm that alerts clinicians when hypotension probability
exceeds an upper threshold;
- And a secondary screen that visually links blood pressure to
hemodynamic flow parameters, such as cardiac output and
contractility.
HPI is part of the Edwards Acumen decision-support software
suite and is enabled by the minimally invasive FloTrac IQ sensor,
the first commercially available technology within the IQ family of
hemodynamic solutions. FloTrac IQ recently received CE Mark.
"European commercial release of the Acumen Hypotension
Probability Indicator builds on a strong foundation of innovation
and provides clinicians with the insights to help them make
decisions earlier," said Catherine M.
Szyman, Edwards' corporate vice president, critical
care.
HPI is planned for a targeted commercial release in Europe in 2016 and a full launch in 2017. It
is not approved for commercial use in the U.S.
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.
Mythen and Ms. Szyman and expectations regarding the product's
potential benefits and availability, as well as future innovations.
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 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, unanticipated outcomes of
longer term clinical experience with the products, or unanticipated
manufacturing, quality, development or regulatory delays or issues.
These and other additional 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. These filings, along with
important safety information about our products, may be found at
www.edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Acumen,
FloTrac, FloTrac IQ, HPI, and Hypotension Probability Indicator are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation