Fresenius Kabi announced that the US Food and Drug Administration (FDA) has granted the company an Investigational Device Exemption (IDE) for the investigational use of the Fenwal Amicus Red Blood Cell Exchange system in treating patients with sickle cell disease.
Fresenius Kabi is working with multiple academic research centers in the United States to study the performance of the Amicus in patients with sickle cell disease. Patient enrollment will begin in the first quarter of 2015.
"This IDE allows Fresenius Kabi to pursue an additional protocol for the Amicus system," said William Cork, Chief Technology Officer, medical devices, Fresenius Kabi.
"Amicus is currently cleared for the collection of apheresis platelets, mononuclear cell collection, and therapeutic plasma exchange. A potential sickle cell protocol would offer a new option for our customers and the patients they serve."
The Amicus Red Blood Cell Exchange (RBC) clinical protocol includes both RBC exchange and a RBC depletion/exchange combination.
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 a normal blood flow.