Terumo Cardiovascular Group has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its CDI blood parameter monitoring system 550.
Image: The CDI blood parameter monitoring system 550 with new parameter for oxygen delivery. Photo: courtesy of PRNewswire / Terumo Cardiovascular Group.
The approval allows CDI blood system to be used in real-time monitoring of oxygen delivery, which is one of 12 critical blood parameters.
The new CDI blood system 550 allows to measure or calculate 12 key parameters, including pH, pCO2, pO2, K+, temperature, SO2, hematocrit, hemoglobin, base excess, bicarbonate, oxygen consumption and oxygen delivery.
Based on industry-standard platform, the next-generation CDI blood system 550 features an advanced optical fluorescence technology, high-visibility LCD screen and better probe design.
Oxygen delivery or DO2 is an indicator of the amount of oxygen being provided to a patient during cardiopulmonary bypass.
According to the company, carefully monitoring DO2 has been demonstrated to help reduce the incidence of acute kidney injury, which is a common complexity of cardiac surgery.
During cardiopulmonary bypass surgery, the continuous in-line monitoring will enable clinicians to quickly make changes in patient status and deliver information on crucial parameters, helping to better manage perfusion cases.
Terumo Cardiovascular Group president and CEO Robert DeRyke said: “For more than 30 years, Terumo’s CDI Systems have been the most trusted and used continuous in-line blood gas monitors for critical blood parameters.
“We are continuing to develop monitoring technologies for the cardiac OR – and beyond – that will improve patient outcomes and result in meaningful value for our customers.”
In May this year, Terumo BCT recruited first patient in the US clinical trial to evaluate the fficacy and safety of red blood cells derived from whole blood, which is treated using its Mirasol system.
The Praise study has been designed to offer the clinical evidence needed to support submission of Mirasol to the FDA for premarket approval (PMA).
Terumo is engaged in the manufacturing and marketing of medical devices for cardiac and vascular surgery, with a focus on cardiopulmonary bypass, intra-operative monitoring and vascular grafting.
Based in Ann Arbor of Michigan, the company has manufacturing operations in the US, Europe and Asia.