Algorithm to predict hypotension during procedures receives FDA clearance

Edwards LifeSciences announced the FDA has granted de novo clearance of its hypotension prediction software for use in procedures.

Using software algorithms, the system (Acumen Hypotension Prediction Index) analyzes CV vital signs and predicts a patient's future CV status or events, according to a press release from the company.

According to the release, the software, which is compatible with Edwards’ hemodynamic monitoring products, consists of the hypotension prediction index, which indicates the likelihood of a hypotensive event before it occurs, an alarm system that alerts clinicians when the index exceeds an upper threshold and a secondary screen that visually links BP with hemodynamic flow parameters to help find the root cause of hypotension.

"Even brief periods of hypotension are associated with complications or, worse, death after surgery," Maxime Cannesson, MD, PhD, professor and vice chair at the department of anesthesiology and perioperative medicine at the University of California, Los Angeles, said in a press release. "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."

According to the release, the system, designated by the FDA as an adjunctive predictive CV indicator, will undergo a targeted launch.

Disclosure: Cannesson reports he is a consultant for Edwards Lifesciences.