The newly cleared Acumen monitor is designed to alert clinicians to potential hypotension, defined as abnormally low blood pressure, for surgical and critical care patients, the Irvine, Calif.-based company said.
“Studies have shown that even short durations of hypotension can be harmful to patients. A 1st-of-its-kind technology that enables clinicians to detect and address potentially developing hypotensive events is a major advance in patient care,” Dr. Monty Mythen, of the University College London, said in prepared remarks.
Edwards said the Acumen hypotension monitor is compatible only with the company’s minimally invasive hemodynamic monitoring solutions.
The device is designed with a machine-learning-equipped hypotension probability parameter, an alarm to alert for possible hypotension events and a secondary screen to visually link blood pressure to hemodynamic flow parameters, the company 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,” critical care corporate VP Catherine Szyman said in a press release.
The company said it’s planning a targeted commercial release this year, with a full launch in Europe in 2017.
Last week, Edwards said it won CE Mark approval for its Inspiris Resilia aortic valve. The company said the valve is the 1st in a “new class of resilient heart valves” which incorporate its Resilia tissue and features a Perimount Magna ease valve and VFit technology for future valve-in-valve procedures.
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