IRVINE, Calif., March 19, 2018 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced that the U.S. Food and
Drug Administration granted the De Novo request for Edwards' Acumen
Hypotension Prediction Index (HPI) software. The company will
initiate a targeted launch of this first-of-its-kind technology
that leverages predictive analytics to alert clinicians to address
potential hypotension, or low blood pressure, before it occurs in
their surgical patients.
"Even brief periods of hypotension are associated with
complications or, worse, death after surgery," said Maxime
Cannesson, MD, PhD, Professor and Vice Chair, Department of
Anesthesiology and Perioperative Medicine, at UCLA. "As blood pressure during surgery decreases,
mortality increases. A software that enables clinicians to detect
and address potentially developing hypotensive events before they
occur is a major and unique advancement in improving patient care."
Designated as an adjunctive predictive cardiovascular indicator
by FDA, the Acumen HPI feature uses software algorithms to analyze
cardiovascular vital signs and predict a patient's future
cardiovascular status or events. The Acumen HPI feature is
only compatible with Edwards' minimally invasive, hemodynamic
monitoring solutions, and comprises three elements:
- The Hypotension Prediction Index, a data driven model developed
from more than 200,000 patient events that indicates the likelihood
of a hypotensive event before it occurs;
- An alarm that alerts clinicians when the Hypotension Prediction
Index exceeds an upper threshold;
- And a secondary screen that visually links blood pressure with
hemodynamic flow parameters, providing a comprehensive view of the
patient's hemodynamics to identify the root cause of the low blood
pressure.
"The Acumen Hypotension Prediction Index is a next-generation,
predictive monitoring software that represents the future of how we
can use patient data to improve healthcare," said Catherine M. Szyman, Edwards' corporate vice
president, critical care. "HPI improves patient care by providing
intelligent decision support, moving beyond descriptive monitoring
to facilitate predictive monitoring, which provides more clarity on
a patient's condition to enable clinicians to make more proactive
decisions."
The HPI feature has CE Mark in Europe. Part of the Edwards Acumen intelligent
decision-support software suite, this feature is unlocked by the
minimally invasive FloTrac IQ sensor.
Dr. Cannesson 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.
Cannesson and Ms. Szyman and expectations regarding the product's
potential benefits. 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, or regulatory developments. 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,
2017. 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 Prediction Index are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation