US-based cardiovascular surgery devices provider Terumo Cardiovascular has received the US Food and Drug Administration (FDA) 510(k) approval for its CDI OneView Monitoring System.
The CDI OneView System provides visibility of key patient parameters during cardiopulmonary bypass surgery, enabling perfusion safety and improved patient outcomes.
The advanced monitoring system measures up to 22 key parameters in real time.
The parameters include measured flow (Q), cardiac index (CI), regional cerebral oxygen saturation (rSO2), oxygen extraction ratio (O2ER), Area Under the DO2 Curve (AUC), and measured arterial oxygen saturation (SaO2).
The CDI OneView Monitoring System provides maximum configurability and flexibility in viewing and prioritising the parameters while providing critical information to clinicians, said Terumo.
Terumo Cardiovascular president and CEO Robert DeRyke said: “The world’s leading cardiac centres have trusted CDI Systems for over 30 years.
“With the launch of the new CDI OneView System, Terumo Cardiovascular continues to bring value and enhanced patient care to healthcare providers and critically ill cardiac patients.
“The CDI OneView System technology is the latest extension of Terumo’s commitment to delivering data-focused solutions to the perfusion community.”
Terumo’s latest patient monitoring system comes with new features and functions, created based on extensive input from perfusionists from cardiovascular institutions worldwide.
The new CDI OneView System offers real-time O2ER, CI, VO2 and DO2 information to help perfusionists maintain a safe threshold for those parameters.
According to independent clinical research, maintaining optimal levels during cardiopulmonary bypass can help reduce the incidence of acute kidney injury.
Terumo Cardiovascular is a subsidiary of Japan-based medical device maker Terumo Corporation, exclusively focused on cardiovascular surgery specialities.
The company is engaged in manufacturing and marketing medical devices for cardiac and vascular surgery with a focus on cardiopulmonary bypass and intra-operative monitoring.
