Fresenius Kabi recently announced that it has received FDA 510(k) clearance for its Fenwal Amicus Red Blood Cell Exchange system.
The system is designed to automate the removal of red blood cells in a patient and replace them with a prescribed replacement fluid. Three new procedures are included in the clearance, including exchange, depletion/exchange and depletion. The procedures give healthcare professionals the flexibility to select what procedure would be best for individual patient needs.
“The Fenwal Amicus Red Blood Cell Exchange system provides U.S. clinicians a new options for red cell exchange for the transfusion management of sickle cell disease in adults and children,” Dean Gregory, president of the medical devices segment at Fresenius Kabi, said in a press release.
Fresenius’s Fenwal Amicus RBCx had been cleared in Europe since 2016. Its separator is also cleared in Europe ad the U.S. for therapeutic plasma exchange, mononuclear cell collection and platelet collection.