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FDA Clears Terumo BCT's PF24 and PF24RT24 Plasma Products


10/8/2012 7:26:00 AM

LAKEWOOD, Colo.--(BUSINESS WIRE)--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.”

About Terumo BCT:

Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

Contacts

Terumo BCT

Laura Fusco, +1-303-205-2546

Global Corporate Communications

press@terumobct.com



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