FDA clears Fenwal's new plasma products

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 Frozen Plasma.