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Terumo Cardiovascular Group Announces 510(k) Clearance for The CDI® Blood Parameter Monitoring System 550, Adding New Parameter For Oxygen Delivery

ANN ARBOR, MICH. — April 20, 2020 — Terumo Cardiovascular, a global leader in cardiovascular surgery technologies, today announced an update regarding its CAPIOX® FX25 Oxygenator in accordance with FDA’s Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, which was issued on April 6, 2020.

CAPIOX FX25 oxygenators are currently indicated for up to six (6) hours of continuous use. While Terumo Cardiovascular does not have FDA approval or clearance for continuous usage of the device for longer than six hours or for ECMO therapy, the above-referenced FDA Guidance designates many hollow fiber oxygenators, including the CAPIOX FX25, as technologically capable of being used for ECMO therapy. 

To support emergency use of this device for ECMO therapy, clinicians may contact Terumo Cardiovascular for relevant performance and durability information, an overview of key risks, a summary of signs indicating that a device change out is necessary, and applicable product part numbers.

Contact Terumo Cardiovascular in the U.S. at 800.521.2818 (Customer Support) or 800.441.3220 (24-hour Technical Support hot line).

About Terumo Cardiovascular
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, 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 cardiovascular surgery specialties. For more information, visit www.terumocv.com

About Terumo
Terumo (TSE:4543) is a global leader in medical technology and has been committed to “;Contributing to Society through Healthcare” for nearly 100 years. Based in Tokyo and operating globally, Terumo employs more than 25,000 associates worldwide, to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been bolstering healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice. Terumo will further strive to be of value to patients, medical professionals, and society at large.

Press Contact:
Melinda Yaklin
Vice President, Corporate Communications Terumo Cardiovascular
Phone: +1 734 741 6068
Email: melinda.yaklin@terumomedical.com