Fresenius Kabi Receives 510(k) Clearance for the Fenwal Amicus RBC Exchange Protocol

Fresenius Kabi announced it has received 510(k) clearance from the U.S. Food and Drug Administration for the Fenwal Amicus Red Blood Cell Exchange (RBCx) system. Fresenius Kabi is a global healthcare company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The Fenwal Amicus RBCx system allows for the automated removal of the patient’s red blood cells and replaces them with a prescribed replacement fluid. It includes three new procedures: exchange, depletion/exchange and depletion. These options give healthcare professionals the flexibility to select the procedure most appropriate for the patient’s needs. “The Fenwal Amicus Red Blood Cell Exchange system provides U.S. clinicians a new option for red cell exchange for the transfusion management of sickle cell disease in adults and children,” said Dean Gregory, president, medical devices, Fresenius Kabi North America. The Fenwal Amicus RBCx system has been cleared in Europe since 2016. The Fenwal Amicus separator is also cleared in Europe and the United States for therapeutic plasma exchange (TPE), mononuclear cell (MNC) collection and platelet collection. – Medical Buyer Bureau