Fresenius Kabi has received 510(k) clearance from the US Food and Drug Administration for the Fenwal Amicus red blood cell exchange (RBCx) system.


Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.

Fresenius Kabi is a global health care 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 health care 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.

Sickle cell disease is an inherited blood disorder that affects red blood cells. People with sickle cell disease have red blood cells that contain mostly hemoglobin S, an abnormal type of hemoglobin.

As a result, these red blood cells become sickle-shaped and have difficulty passing through small blood vessels preventing blood to reach all parts of the body which in turn damages tissue that does not receive normal blood flow.

Source: Company Press Release