Fresenius Kabi AG Receives FDA 510(k) Clearance for the Aurora Xi Plasmapheresis System

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today it has received FDA 510(k) clearance for the Aurora™ Xi Plasmapheresis System.

“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 is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.

“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,” 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 is the liquid portion of blood that contains valuable proteins used to treat burn victims, bleeding disorders, human immune deficiencies, and other chronic or genetic disorders. Patients who rely on plasma protein therapies often require regular infusions or injections throughout their lives.

Source Plasma is collected exclusively through plasmapheresis, 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).

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. In transfusion medicine, Fresenius Kabi offers the Fenwal family of transfusion technologies, including the Amicus and Alyx cell separators, the Aurora and Aurora Xi plasmapheresis systems and Fenwal Blood Pack Units. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany.