Fresenius Kabi secures FDA 510(k) clearance for Aurora Xi Plasmapheresis System

10 October 2016 (Last Updated October 10th, 2016 18:30)

Fresenius Kabi has received FDA 510(k) clearance for the Aurora Xi Plasmapheresis System.

Fresenius Kabi has received FDA 510(k) clearance for the Aurora Xi Plasmapheresis System.

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 maximise the volumes of plasma they collect while assuring a good experience for plasma donors.”

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

Patients who depend on plasma protein therapies often require regular infusions or injections throughout their lives.

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

Source Plasma is collected only through plasmapheresis, which 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 to manufacture plasma-based therapies, such as albumin and intravenous immunoglobulin (IVIG).

Fresenius Kabi is a health care company specialising in medicines and technologies for infusion, transfusion and clinical nutrition.


Image: Aurora Xi Plasmapheresis System. Photo: Courtesy of Business Wire / Fresenius Kabi.