Edwards Lifesciences (EW) Announces Receipt of CE Mark for Acumen HPI

October 3, 2016 6:09 AM EDT

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Edwards Lifesciences Corporation (NYSE: EW) 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.

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