FDA clears Fenwal's TPE on the Amicus separator

The U.S. Food and Drug Administration has cleared Fenwal to market a therapeutic plasma exchange protocol for the company's Amicus^® separator, Fenwal announced today.    

The Amicus separator from Fenwal is now one of the most advanced cell separation systems available for therapeutic plasma exchange and mononuclear cell collection, which are used to treat a wide variety of diseases and for clinical research.

Therapeutic plasma exchange, or TPE, removes substances from blood to help reduce symptoms associated with certain diseases. The procedure is performed in hospitals primarily to treat auto-immune diseases, including hematologic, neurologic, and kidney disorders.

In clinical trials, TPE on the Amicus separator achieved high plasma removal efficiency and low platelet loss, while maintaining accurate fluid balance control. In addition to its therapeutic protocols, the Amicus separator from Fenwal is used today throughout the world to collect donated platelets, concurrent plasma and red cells.

"Clearance for TPE on the Amicus separator allows hospitals to perform two advanced therapeutic procedures - TPE and stem cell collections - using one instrument," said William H. Cork, chief technology officer for Fenwal. "This is the sort of versatility cost-conscious hospitals need, and with the Amicus system there is no compromise in performance. The Amicus separator provides high efficiency and yield purity - it is truly one of the most advanced blood and cell separation technologies available."

The Amicus separator with TPE uses a disposable collection kit set to draw blood from patients, remove the plasma containing harmful proteins, and return to the patient his or her 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 protocol is also available for the Amicus separator in Europe and Latin America.