Fresenius Kabi (NYSE:FMS) said today that it won FDA 510(k) clearance for its Aurora Xi plasmapheresis system.
Plasma, a component of blood that contains proteins, is used in therapies to treat burn victims, bleeding disorders, and other chronic and genetic problems. Patients who require plasma infusions or injections have to get them regularly and often for life.
Plasmapheresis is a method of removing blood a donor and separating it into plasma and cells. The red blood cells and platelets are returned to the donor, while the plasma can be used to create plasma-based therapeutics such as albumin and intravenous immunoglobulin.
“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,” medical device president Dean Gregory said in prepared remarks. “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.”
In August, the Lake Zurich, Ill.-based company said it is investing approximately $250 million over 10 years to expand Melrose Park, its generic, injectable pharmaceutical manufacturing site. The plant will be expanded into a manufacturing campus with ground breaking planned for 2017 and completion slated for 2026.
