Terumo Cardiovascular Group Announces 510(k) Clearance for the CDI® Blood Parameter Monitoring System 550, Adding New Parameter for Oxygen Delivery
ANN ARBOR, Mich., Nov. 14, 2018
ANN ARBOR, Mich., Nov. 14, 2018 /PRNewswire/ -- Terumo Cardiovascular Group, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI® Blood Parameter Monitoring System 550, adding real-time monitoring of oxygen delivery as one of 12 critical blood parameters.
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.1
"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," said Robert DeRyke, President and CEO of Terumo Cardiovascular Group. "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."
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.
The new CDI System 550 measures or calculates these 12 key parameters: pH, pCO2, pO2, K+, temperature, SO2, hematocrit, hemoglobin, base excess, bicarbonate, oxygen consumption and oxygen delivery.
Building on an industry-standard platform, the next-generation CDI System 550 offers market-leading optical fluorescence technology, a high-visibility LCD screen, advanced probe design, and IEC 60601-1 3rd Edition compliance.
- Ranucci M, Romitti F, Isgro G, et al. Oxygen Delivery During Cardiopulmonary Bypass and Acute Renal Failure After Coronary Operations. Ann Thorac Surg. 2005;80:2213-20.
About Terumo Cardiovascular Group
Terumo Cardiovascular Group manufactures and markets medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. The company is headquartered in Ann Arbor, Michigan, with manufacturing operations in the U.S., Europe and Asia. It is one of several subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiac and vascular specialties. For more information, visit www.terumo-cvgroup.com.
About Terumo Corporation
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers, with over US$5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices, including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician-office use. Terumo contributes to society by providing valued products and services to the healthcare market, and by responding to the needs of healthcare providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
CDI® is a registered trademark of Terumo Cardiovascular Systems. 892284
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SOURCE Terumo Cardiovascular Group