Cardiovascular surgery company Terumo Cardiovascular Group revealed on Wednesday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance for the CDI Blood Parameter Monitoring System 550 with new parameter for oxygen delivery.
The company said the oxygen delivery, or DO2, is an indicator of the amount of oxygen being delivered to a patient during cardiopulmonary bypass. Carefully monitoring DO2 has been shown to help reduce the incidence of Acute Kidney Injury, a common complication of cardiac surgery.
According to the company, the new CDI System 550 measures or calculates the 12 key parameters: pH, pCO2, pO2, K+, temperature, SO2, hematocrit, hemoglobin, base excess, bicarbonate, oxygen consumption as well as oxygen delivery.
In conjunction, the company's next-generation CDI System 550 offers market-leading optical fluorescence technology, a high-visibility LCD screen, advanced probe design, as well as IEC 60601-1 3rd Edition compliance.
Continuous in-line monitoring during cardiopulmonary bypass surgery is a critical component of perfusion safety. It quickly alerts clinicians to changes in patient status and delivers information on key parameters that helps clinicians manage perfusion cases, concluded the company.
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