FDA clears Terumo BCT's PF24 and PF24RT24 plasma products

Published on October 8, 2012 at 3:03 AM · No Comments

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.

KEY FACTS:

  • 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.

KEY QUOTES:

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."

Source:

Terumo BCT

Posted in: Device / Technology News | Medical Science News

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