Edwards' Acumen Hypotension Prediction Index Launches In The U.S.

IRVINE, Calif., March 19, 2018 - Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the U.S. Food and Drug Administration granted the De Novo request for Edwards' Acumen Hypotension Prediction Index (HPI) software. The company will initiate a targeted launch of this first-of-its-kind technology that leverages predictive analytics to alert clinicians to address potential hypotension, or low blood pressure, before it occurs in their surgical patients.

"Even brief periods of hypotension are associated with complications or, worse, death after surgery," said Maxime Cannesson, MD, PhD, Professor and Vice Chair, Department of Anesthesiology and Perioperative Medicine, at UCLA. "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."

Designated as an adjunctive predictive cardiovascular indicator by FDA, the Acumen HPI feature uses software algorithms to analyze cardiovascular vital signs and predict a patient's future cardiovascular status or events. The Acumen HPI feature is only compatible with Edwards' minimally invasive, hemodynamic monitoring solutions, and comprises three elements:

• The Hypotension Prediction Index, a data driven model developed from more than 200,000 patient events that indicates the likelihood of a hypotensive event before it occurs;
• An alarm that alerts clinicians when the Hypotension Prediction Index exceeds an upper threshold;
• And a secondary screen that visually links blood pressure with hemodynamic flow parameters, providing a comprehensive view of the patient's hemodynamics to identify the root cause of the low blood pressure.

"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," said Catherine M. Szyman, Edwards' corporate vice president, critical care. "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."

The HPI feature has CE Mark in Europe. Part of the Edwards Acumen intelligent decision-support software suite, this feature is unlocked by the minimally invasive FloTrac IQ sensor.

Dr. Cannesson is a consultant to Edwards Lifesciences.

About Edwards Lifesciences

Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.edwards.com.