Fenwal has received the US Food and Drug Administration (FDA) approval for therapeutic plasma exchange (TPE) on Its Amicus separator.
The Amicus separator with TPE uses a disposable collection kit to draw blood from patients, remove the plasma containing harmful proteins, and return to the patient’s own red cells, platelets and a plasma-replacement fluid containing saline, human albumin or other components.
The continuous-flow TPE protocol on the Amicus separator is designed to simplify the procedure and automate certain manual steps to allow the operator more time to focus on the patient.
The TPE procedure is performed in hospitals to treat auto-immune diseases including hematologic, neurologic and kidney disorders.
Fenwal chief technology officer William Cork said clearance for TPE on the Amicus separator allows hospitals to perform two therapeutic procedures – TPE and stem cell collections – using one instrument.