Hemodynamic Monitor Cleared by FDA

A new monitoring system that provides doctors with a complete picture of blood circulation in a patient's heart has been cleared by the U.S. Food and Drug Administration (FDA). The data provided are intended to help doctors make rapid decisions when treating patients in emergency rooms and surgical and critical care settings.

The monitoring system provides automatic, continuous measurement of a patient's end-diastolic volume (EDV), cardiac output (CO), and mixed venous oxygen saturation (SvO2). EDV measures the fluid volume available in the heart to support adequate blood circulation, a key measure for doctors who need to provide optimal therapy for critically ill and injured patients. Called Vigilance, the system permits hands-free measurements. It is the product of Edwards Lifesciences Corp. (Irvine, CA, USA) and is designed to work in conjunction with the CCOmbo catheter technology of Edwards.

"The addition of continuous end diastolic volume measurement represents the latest innovation in Swan-Ganz catheter technology and builds on the industry-leading line of catheters that Edwards pioneered more than 30 years ago,” noted Michael A. Mussallem, chairman and CEO of Edwards Lifesciences.