FDA clears Terumo BCT's PF24 and PF24RT24 plasma products
Published on October 8, 2012 at 3:03 AM
Terumo BCT has received clearance for the preparation of plasma held at
1° to 6° C within 8 hours and frozen within 24 hours after phlebotomy
(PF24) and plasma held at room temperature for up to 24 hours and frozen
within 24 hours after phlebotomy (PF24RT24) from apheresis plasma
collected on Terumo BCT's Trima
Accel Automated Blood Collection System. The clearance of these
extended handling capabilities enables blood centers to collect the
right product at the right time and leverage the mobility of the Trima
Accel system for collections farther from the processing laboratory,
such as satellite collection centers and mobile blood drives.
FDA's clearance of PF24 and PF24RT24 on the Trima Accel system is an
opportunity to prepare plasma products from apheresis plasma collected
at remote collection facilities and blood drives. Blood centers now
have 24 hours before the product must be frozen.
PF24 and PF24RT24 plasma products are indicated for replacement of
non-labile clotting factors.
Clearance of PF24 and PF24RT24 has the potential to increase
collection of plasma, and the availability of plasma from Type AB
blood donors, the "universal donor" for plasma.
Mark Holmes, Vice President, Government and Regulatory Affairs
"FDA's clearance of PF24 and PF24RT24 on the Trima Accel system enables
customers to collect more plasma from mobile and satellite blood drives.
Terumo BCT is excited about the greater collection options this presents
customers, whether their collection site is one or many hours away. This
increased time allowance before freezing has the potential to greatly
increase plasma availability in the U.S., and help more patients, with
the right product, at the right time."