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.
The Amicus® separator is an advanced cell separation device
with multiple component collection and therapeutic protocols, and is
cleared for use with the Fenwal InterSol® platelet additive
solution. The InterSol® solution replaces a portion of the
plasma stored with platelets, allowing the plasma to be used for other
therapeutic purposes. This latest clearance provides blood centers more
flexibility in processing this additional plasma for transfusion.
Plasma is the liquid portion of blood that contains vital proteins used
to treat burn victims, bleeding disorders, human immune deficiencies,
and other chronic or genetic disorders. Nearly 5 million units of plasma
are transfused annually in the United States. Unlike other blood
components, which are stored at room temperature or refrigerated, plasma
is frozen and thawed prior to transfusion.
According to the new indications, plasma products collected on the Alyx®
and Amicus® systems 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. If kept at room
temperature and frozen within 24 hours of phlebotomy, it can be labeled
as PF24RT24. These new products are indicated for the replacement of
non-labile clotting factors. They are not considered equivalent to Fresh