The US Food and Drug Administration (FDA) has approved Fresenius Kabi's Aurora Xi plasmapheresis system.

The automated plasmapheresis system, which features Aurora Xi instrument and Plasmacell Xi disposable set, will be used to collect cell-free plasma for processing as Source Plasma.

It uses a rapidly rotating separator (membrane filter) to separate whole blood into plasma for collection and concentrated cells for reinfusion to the donor.

According to the company, the plasma collection by the Aurora Xi system is a fully automated procedure with the donor connected to the Plamscell Xi disposable set throughout the collection process.

Plasma is the liquid portion of blood, which contains valuable proteins used to treat burn victims, bleeding disorders, human immune deficiencies, and other chronic or genetic disorders

Fresenius Kabi USA medical devices president Dean Gregory said: “The Aurora Xi system features a proprietary filtration-separation method that enables the faster collection of Source Plasma.

“The system helps to improve plasma center efficiency and the overall experience for operators and donors.

“Faster collection times mean more throughput for our customers, helping maximize the volumes of plasma they collect while assuring a good experience for plasma donors.”

Fresenius Kabi produces medicines and technologies for infusion, transfusion and clinical nutrition.

The firm produces Fenwal family of transfusion technologies, including Amicus and Alyx cell separators, Aurora and Aurora Xi plasmapheresis systems and Fenwal blood pack units.


Image: Fresenius Kabi’s Aurora Xi plasmapheresis system. Photo: courtesy of Business Wire.