FDA clears EV1000 clinical monitoring platform


The US Food and Drug Administration (FDA) has given 510(k) clearance to Edwards Lifesciences for its new EV1000 clinical monitoring platform, a touch-screen monitor that displays a patient’s physiologic status and user-friendly clinical targets and alerts, designed to simplify decision-making in the operating room and intensive care unit. 

“I believe the key to improving patient outcomes in the operating room and intensive care unit is having continuous, real-time information about a patient’s haemodynamic status at your fingertips,” said Steve Woodford, director of Intensive Care, Brisbane Waters Private Hospital, Australia. “The EV1000 clinical platform gives me the patient data that I need on one intuitive display that enables me to quickly decide the next course of treatment for my patients.”

The EV1000 clinical platform has been available in Europe and Australia since November 2010 and recently won the gold award in the Critical Care and Emergency Medicine Products category at Medical Device + Diagnostic Industry Magazine’s Medical Design Excellence Awards competition in New York City.

About the EV1000 clinical platform

The EV1000 clinical platform allows patient data to be displayed on the clinician’s choice of several different screens with the aim simplify the display and retrieval of haemodynamic information and expand its applicability. The platform utilise color-coding and physiologic representation of the cardiovascular circulation to reflect patient status and enable decision-making. The company’s FloTrac sensor, PreSep and PediaSat oximetry catheters, and TruWave disposable pressure transducer are compatible with this platform.