FDA Clears Edwards Lifesciences’ Advanced Noninvasive Hemodynamic Monitoring System

Edwards Lifesciences Corporation has received U.S. FDA clearance for the ClearSight system, a noninvasive monitor that 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.

Background

Hemodynamic monitoring is the measurement of blood circulation and cardiac function that allows clinicians to evaluate whether enough oxygen is being delivered to the organs and tissues. Healthcare providers use this information to detect changes or problems in a patient’s health, which allows for more informed, immediate treatment decisions.

Connected to the Edwards EV1000 clinical platform, the ClearSight system uses a cuff on the outside of the finger. It utilizes Edwards’ proven, gold-standard monitoring technologies that are used in hospitals around the world, and incorporates a finger cuff and software elements that the company tells us have been used for the noninvasive monitoring of the blood pressure of astronauts in space.

The ClearSight system automatically provides up-to-the-minute information without inserting anything into the body. The company claims this provides an opportunity to extend the benefits of hemodynamic optimization, or proper fluid administration and balance within a patient’s organs and tissues, to a broader patient population that could benefit from close monitoring, but may not receive it without a noninvasive option.

Physician comments

“Proper intraoperative management of moderate and high-risk surgery patients is critical to help reduce the risk of post-surgical complications,” said Julie K. Thacker, M.D., surgical oncologist at Duke University Hospital. “Studies have indicated that patient outcomes are improved through monitoring and management of vital hemodynamic information through hemodynamic optimization protocols.”

Company comments

“The ClearSight system is the most advanced noninvasive monitor of its kind. 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,” said Carlyn D. Solomon, Edwards’ corporate vice president, critical care and vascular.

Source: Edwards Lifesciences Corporation

 

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