FDA clears Fenwal's Aurora plasmapheresis system

The U.S. Food and Drug Administration has cleared for marketing a new source plasma collection system developed by Fenwal, Inc., the company announced today. Called the Aurora™ plasmapheresis system, the new device can support two-way, wireless data communication designed to eliminate manual steps and increase operator and donor satisfaction.    

"Aurora is a significant innovation for plasma collection professionals," said William Cork, Fenwal chief technology officer. "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."

The Aurora system is the latest advancement in plasma collection technology from Fenwal. The system builds on the proprietary separation technology that powers the company's Autopheresis-C^® system, which has been used worldwide to collect plasma for more than 20 years.

Plasmapheresis is an automated process in which plasma is taken from donated blood and the remaining components - primarily red cells and platelets - are returned to the donor. Source plasma is used by pharmaceutical companies that produce therapies from plasma-derived proteins.

Plasma-collection professionals played an integral role in the development of Aurora. "From the layout of the system to the onscreen prompts, every detail was evaluated for ease of use, safety, and enhanced productivity," Cork said. "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."

The Aurora system also offers custom features that improve work flow and help assure a successful collection. Intuitive on-screen instructions simplify training for operators, and provide troubleshooting assistance. A new LCD display allows donors themselves to see how their donation is progressing.

The Aurora system can support remote procedure set up, paperless documentation, and 21 CFR Part 11 compliance when combined with the DXT^® Relay software and a plasma center's donor management software. With remote procedure set up, the Aurora^™ system can be automatically programmed based on donor registration information. These features help assure data accuracy, documentation compliance, and streamline the set-up procedure.

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. The reports track specific performance indicators and can be used to identify opportunities for improvement and training.