Edwards gets CE mark for its hypotension indicator

Edwards Lifesciences ($EW) has received a CE mark for its hypotension indicator, which alerts healthcare clinicians to the potential of abnormally low blood pressure in surgical and critical care patients before such an event occurs.

The device, dubbed the Acumen Hypotension Probability Indicator (HPI), is only compatible with the company’s minimally invasive, hemodynamic monitoring solutions. It is expected to be available in Europe later this year with a full launch planned for 2017, the company said. The HPI is not approved for commercial use in the U.S.

"Studies have shown that even short durations of hypotension can be harmful to patients," Monty Mythen, the Smiths Medical Professor of Anesthesia and Critical Care at University College London, said in a statement. "A first-of-its-kind technology that enables clinicians to detect and address potentially developing hypotensive events is a major advance in patient care.”


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The device, which was developed using machine learning technology, alerts clinicians when hypotension probability reaches an upper threshold while a secondary screen monitors blood pressure to hemodynamic flow parameters, such as cardiac output and contractility. The system uses Edwards’ FloTrac IQ sensor, which recently received a CE mark.

Last month, Edwards got a CE mark to expand the indication of its Sapien 3 TAVR to cover aortic stenosis patients who are at intermediate risk for open-heart surgery. That news followed the FDA’s decision in August to expand the device’s indication to include intermediate-risk patients.

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