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.”


Join the world's top medtech executives virtually for the leading event in medtech — The Virtual MedTech Conference by AdvaMed

Expect the same high-quality education, world-class speakers and valuable business development in a virtual format. Experience more of the conference with on demand content and partnering, as well as livestreamed sessions.

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.

Suggested Articles

The company describes the continuous glucose monitor as the world’s smallest and thinnest diabetes sensor, with a disc about the size of two pennies.

AI-based drug molecule designer XtalPi has secured a mammoth funding round totaling $318.8 million, from global banking and tech investors.

LabCorp has licensed a blood test from Genfit designed to identify patients with risky cases of the liver disease NASH.