Terumo Cardiovascular gains US FDA clearance for CDI OneView monitoring system

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The CDI OneView System

Terumo Cardiovascular has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI OneView monitoring system.

The next-generation CDI Systems platform provides visibility of key patient parameters during cardiopulmonary bypass surgery, critical to perfusion safety and improving patient outcomes.

The new CDI OneView System measures or displays up to 22 key parameters, the newest of which are 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 system offers maximum configurability and flexibility in how the parameters can be viewed and prioritised to best suit clinical needs and preferences, while continuing to provide the critical information on which clinicians have come to rely, Terumo Cardiovascular says in a press release.

“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,” said Robert DeRyke, president and CEO of Terumo Cardiovascular. “The CDI OneView System technology is the latest extension of Terumo’s commitment to delivering data-focused solutions to the perfusion community.”

New features and functions of Terumo’s latest patient parameter monitoring system were influenced by extensive perfusionist input from leading global cardiovascular institutions. The new CDI OneView System now provides real-time O2ER, CI, VO2 and DO2 information to help perfusionists maintain a safe threshold for those parameters.

Independently published and reviewed clinical research indicates that maintaining optimal levels during cardiopulmonary bypass can help to reduce the incidence of acute kidney injury.


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