FDA Clears First Automated Whole Blood Processing System In U.S.

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 03 Jul 2008 - 3:00 PDT

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Gambro BCT, Inc., soon to be known as CaridianBCT, a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies, announced that it received FDA clearance for the commercial sale of Atreus® Whole Blood Processing system in the United States. The Atreus system is the first self-contained, automated manufacturing system cleared for distribution in the U.S.

The Atreus system includes both automation and informatics capabilities. The Atreus device automates the manufacturing process of a unit of whole blood. Replacing balances, centrifuges, expressers, sealers, and scales, the Atreus system significantly reduces variability from the manufacturing process. In the future, the company also will distribute specialized tubing kits, including a single collect bag and a compatible processing kit. The initial offering allows blood centers to leukoreduce the Red Blood Cell unit by gravity filtration after processing.

"Our system is truly revolutionizing the blood banking industry by simplifying whole blood processes through automation and informatics," said Senior Vice President and General Manager, Whole Blood Processes, Michael Seely. "The combination of automation and informatics provides consistently high product quality, standardizes business processes and allows for scalability and flexibility."

The Atreus system includes an integrated, user-friendly web application that configures the Atreus device(s), defines workflow, automates data capture, generates data-rich managerial reports and centralizes documentation for enhanced regulatory control. The company has worked with its customers in Europe to establish data transfer from the Atreus system to the respective blood bank information systems. It will evaluate a similar strategy for customers within the U.S.

"We are dedicated to developing and commercializing technology innovations that serve our customers in the blood banking and transfusion medicine industry," said President and Chief Executive Officer David B. Perez. "This 510(k) clearance reflects our commitment to investing in research and development focused on enhancing blood quality, safety, supply and efficiency."

About CaridianBCT

Gambro BCT will change its name to CaridianBCT, Inc. on July 14, 2008. The company improves lives through innovation, quality and services delivered by its people, products and processes in blood component technology. It is a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies - serving blood banks, hospitals and clinical and biotech research facilities. Headquartered in Lakewood, CO., the company has global operations in 32 countries and employs more than 2,300 people.

CaridianBCT