Edwards’s ClearSight monitoring system gets FDA clearance

30 June 2014 (Last Updated June 30th, 2014 18:30)

US-based Edwards Lifesciences has secured clearance from the US Food and Drug Administration (FDA) for the ClearSight system, a noninvasive monitor.

Edwards ClearSight system

US-based Edwards Lifesciences has secured clearance from the US Food and Drug Administration (FDA) for the ClearSight system, a noninvasive monitor.

The system provides clinicians access to valuable blood volume and blood flow information for patients at moderate or high risk of post-surgical complications, in whom invasive monitoring would not be used.

The ClearSight system uses a cuff on the outside of the finger that is connected to the Edwards EV1000 clinical platform.

The system uses the company's monitoring technologies that are used in hospitals worldwide, and also includes a finger cuff and software elements that have been used for the noninvasive monitoring of the blood pressure of astronauts in space.

Compared with the traditionally more invasive approach to monitoring, the new ClearSight system automatically offers up-to-the-minute information without inserting anything into the body.

"Studies have indicated that patient outcomes are improved through monitoring and management of vital hemodynamic information through hemodynamic optimisation protocols."

The monitoring system will also help in extending the benefits of hemodynamic optimisation, or proper fluid administration and balance within a patient's organs and tissues, in order to a broader patient population that could benefit from close monitoring, but may not receive it without a noninvasive option.

Duke University Hospital surgical oncologist Julie Thacker said: "Studies have indicated that patient outcomes are improved through monitoring and management of vital hemodynamic information through hemodynamic optimisation protocols."

The company said that the ClearSight advanced noninvasive monitoring system is also available in CE Mark countries.

Edwards corporate vice-president of critical care and vascular Carlyn Solomon said: "This important development in the field of critical care medicine builds on Edwards' 40 years of experience in providing clinicians with tools to make more informed decisions that can advance patient care by helping to reduce complications, shorten hospital stays and lower associated costs."


Image: Edwards' ClearSight system extends valuable dynamic and flow-based HD management to a broader patient population. Photo: courtesy of PRNewswire/ Edwards Lifesciences Corporation.