Terumo monitoring system gets FDA review

ANN ARBOR–The Ann Arbor-based cardiovascular surgery technology developer Terumo Cardiovascular, announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the CDI OneView Monitoring System.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.

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

Built on decades of technology, Terumo’s new CDI OneView System measures or displays up to 22 vital patient parameters — including oxygen delivery, cardiac index, area under the indexed oxygen delivery curve, oxygen extraction ratio and measured flow.

This innovative system offers maximum configurability and flexibility in how the parameters can be viewed and prioritized to best suit clinical needs and preferences, while continuing to provide the critical information on which clinicians have come to rely.

“The world’s leading cardiac centers 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. In response to the growing needs of healthcare providers, 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.

Terumo Cardiovascular manufactures and markets medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass and intra-operative monitoring. The company is headquartered in Ann Arbor, with manufacturing operations in the United States, Asia, and Latin America. It is one of several subsidiaries of Terumo Corp. of Japan that is focused exclusively on cardiovascular surgery specialties. For more information, visit www.terumocv.com

Terumo Corp. is based in Tokyo and employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a thermometer manufacturer. Now, its business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments.

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