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The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aurora™ Xi Plasmapheresis System.
The system collects plasma from donated blood and returns the remaining blood components to the donor.
The Aurora Xi Plasmapheresis System features a proprietary filtration-separation method that enables faster collection of source plasma, according to Fresenius Kabi, the company marketing the system.
“The system helps to improve plasma center efficiency and the overall experience for operators and donors,” said Dean Gregory, president, medical devices, Fresenius Kabi USA.
“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.”
Plasma collected via the Aurora Xi Plasmapheresis System can be used to treat bleeding disorders, burn victims, human immune deficiencies, and other chronic or genetic disorders.
The plasma can also be used to manufacture therapies such as albumin and intravenous immunoglobulin.
