FDA clears Fenwal's new plasma products

Published on October 8, 2012 at 2:50 AM · No Comments

Fenwal Inc., a global leader specializing in separation technologies for blood and cell collection and therapy, announced today it has received clearance from the U.S. Food and Drug Administration for two new indications for collection of plasma products on the Fenwal Alyx® and Amicus® systems.

The new indications permit new plasma products collected on the Fenwal Alyx® and Amicus® systems to be held up to 24 hours before freezing. These systems are already cleared to collect Fresh Frozen Plasma, which is frozen within eight hours.

"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," said Dean Gregory, Fenwal senior vice president of Commercial Operations. "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."

The Fenwal Alyx® system is a fast, portable cell separation device used to collect two units of red cells, or red cells and plasma from qualified donors. These new plasma processing options when used with the Alyx® system can provide blood centers more flexibility to collect plasma on mobile blood drives.

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