The US Food and Drug Administration (FDA) has granted clearance to Fenwal for two new indications for collection of plasma products on its cell separation devices, thus providing blood centers more flexibility to collect plasma on mobile blood drives.
The new indications permit new plasma products collected on the Fenwal Alyx and Amicus systems to be held up to 24 hours before freezing.
The Fenwal Alyx system is used to collect two units of red cells, or red cells and plasma from qualified donors, while the Amicus separator has multiple component collection and therapeutic protocols and is cleared for use with the Fenwal InterSol platelet additive solution.
The company said the new indications for plasma products collected on the cell separation devices using the Fenwal ACD-A anticoagulant may now be labeled as PF24, if stored at 1-6 degrees Celsius within eight hours of phlebotomy and frozen within 24 hours.
Fenwal commercial operations senior vice president Dean Gregory said there is a growing demand for plasma for transfusion, however the need to freeze the products within eight hours has made it challenging for blood centers to meet the processing requirements, especially on mobile blood drives.
"Now we can offer blood center professionals greater time flexibility in collecting plasma products on the Alyx and Amicus systems, and that should help increase collections and availability of this critical blood component," Gregory added.