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Fenwal's Aurora Gets U.S. Food and Drug Administration Clearance for Marketing

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April 04, 2012

Fenwal's Aurora Gets U.S. Food and Drug Administration Clearance for Marketing

By Jayashree Adkoli, TMCnet Contributor

Plasma, the liquid portion of blood that contains valuable proteins, is used in treating burn victims, bleeding disorders, human immune deficiencies and other chronic or genetic disorders. The plasma-derived proteins have currently become integral to many novel medical therapies in late-stage development.

An automated process called Plasmapheresis is generally conducted to collect plasma. This source plasma is used by pharmaceutical companies that produce therapies from plasma-derived proteins. And generally, the plasma-collection is done by professionals.

Fenwal, a global blood technology company dedicated to supporting transfusion medicine and cell therapies, had recently rolled out a new plasmapherisis system called Aurora. Now, the U.S. Food and Drug Administration (FDA) department has cleared the new source plasma collection system for marketing.

The Aurora source plasma collection system supports two-way, wireless data communication. It is designed to eliminate manual steps and increase operator and donor satisfaction. As the latest advancement in plasma collection technology from the company, the Aurora system is built on the proprietary separation technology that powers the company’s Autopheresis-C system.

Offering custom features that improve work flow and help assure a successful collection, the The Aurora system is incorporated with intuitive on-screen featuring instructions to simplify training for operators, and provide troubleshooting assistance.

In addition, the Aurora system also provides a new LCD display that allows donors themselves to see how their donation is progressing. It can also support remote procedure set up, paperless documentation and 21 CFR Part 11 compliance, when combined with the DXT Relay software and plasma center’s donor management software.

The DXT Relay software provides plasma center professionals with easy-to-read, on-demand reports that aggregate donor and procedure data from multiple Aurora systems at different locations. According to Fenwal, the reports track specific performance indicators and can be used to identify opportunities for improvement and training.

“Aurora is a significant innovation for plasma collection professionals,” said William Cork, chief technology officer at Fenwal, in a statement. “Aurora features powerful new capabilities, such as an interactive touch-screen display with intuitive menus and icons, and comes with the Fenwal DXT Relay software, which delivers productivity reports and enables remote procedure set-up and paperless documentation.”

“From the layout of the system to the onscreen prompts, every detail was evaluated for ease of use, safety, and enhanced productivity,” added Cork. “Similarly, the data-management software was built with open architecture so that it can seamlessly integrate with existing plasma center systems without requiring expensive, proprietary add-ons.”

Edited by Jennifer Russell

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