LAKE ZURICH, Ill., February 5, 2015 – Fresenius Kabi, a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition, announced today that the U.S. 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.
About Sickle Cell Disease
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.
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. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.