Edwards Lifesciences has secured CE mark approval for its Acumen hypotension probability indicator (HPI).
The new technology enables clinicians to manage hypotension or abnormally low blood pressure in their surgical and critical care patients before it occurs.
Part of the Edwards Acumen decision-support software suite, the new HPI is only compatible with the firm’s minimally invasive and hemodynamic monitoring solutions.
It will be enabled by the minimally invasive FloTrac IQ sensor, which recently secured CE mark approval.
HPI features hypotension probability parameter, which depicts possibility of a hypotensive event using machine learning techniques developed from more than 20,000 past patient events.
It also includes an alarm that alerts clinicians when hypotension probability exceeds an upper threshold.
In addition, the HPI features secondary screen that visually links blood pressure to hemodynamic flow parameters such as cardiac output and contractility
The company is planning a targeted commercial release of the HPI in Europe this year, while a full launch in the next year.
The new HPI is not yet received approval for commercial use in the US.
Edwards' critical care corporate vice president Catherine Szyman said: "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.”
Edwards is engaged in the development of medical solutions for structural heart disease, as well as critical care and surgical monitoring.