Edwards Lifesciences (NYSE:EW) said today it won FDA de novo approval for its Acumen Hypotension Prediction Index software designed to address potential hypotension in surgical patients.
The Irvine, Calif.-based company said it is engaging in a targeted launch of the system in the US following the approval, which clears the software as an adjunctive predictive cardiovascular indicator.
“The Acumen Hypotension Prediction Index is a next-generation, predictive monitoring software that represents the future of how we can use patient data to improve healthcare. HPI improves patient care by providing intelligent decision support, moving beyond descriptive monitoring to facilitate predictive monitoring, which provides more clarity on a patient’s condition to enable clinicians to make more proactive decisions,” Edwards critical care corp. VP Catherine Szyman said in a press release.
The HPI software uses algorithms to analyze cardiovascular vital signs to predict future events and cardiovascular status, Edwards said. The system is only compatible with Edwards hemodynamic monitoring solutions. Analytics within the HPI are powered by a data driven model developed from more than 200,000 patient events.
The system includes the HPI software, an alarm to alert when the HPI exceeds the upper threshold and a secondary screen to link blood pressure and hemodynamic flow parameters to identify causes of low blood pressure, the company said.
“Even brief periods of hypotension are associated with complications or, worse, death after surgery. As blood pressure during surgery decreases, mortality increases. A software that enables clinicians to detect and address potentially developing hypotensive events before they occur is a major and unique advancement in improving patient care,” Dr. Maxime Cannesson of UCLA said in a prepared statement.
Earlier this month, reports emerged that Edwards Lifesciences is planning to build a plant in Ireland that could employ as many as 600 workers by 2020.
