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.