Edwards Receives CE Mark For Hypotension Probability Indicator

10/03/2016
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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.