Terumo receives FDA approval to evaluate PMN cell collection protocol
Jan 08, 2013 (Datamonitor via COMTEX) --
Terumo BCT, Inc., which designs, develops, and supplies blood component technology solutions, has received approval from the FDA to conduct a controlled evaluation of the polymorphonuclear, or PMN, cell collection protocol on its next-generation apheresis platform, the Spectra Optia system.
Donor PMN cells (specifically neutrophils), given to patients via transfusion, may help prevent infection in those patients who have limited infection-fighting white cells due to disease or chemotherapy treatment. In patients who have already developed severe infections and are at a higher risk of mortality, transfused PMN cells may help fight the infection until the patient's immune system is restored.
Terumo BCT received approval from the FDA for a controlled evaluation of the Spectra Optia system's PMN cell, or granulocyte, collection protocol at up to four US sites. This study will evaluate the performance (collection efficiency and yield), usability and safety of the Spectra Optia system's PMN cell collection protocol.
The above protocols, in addition to red blood cell exchange (RBCX), are available in Canada. Eight procedures are available in Europe, Australia, Africa, the Middle East and select areas of Asia: TPE, MNC, RBCX, TPE with single-needle access, TPE with a secondary plasma device, granulocyte collections, and white blood cell depletions and platelet depletions.
In addition to the Spectra Optia system, Terumo BCT continues to support its entire range of therapeutic platforms, including the COBE Spectra Apheresis System, the Elutra Cell Separation System and the COBE 2991 Cell Processor.
Bob Sullivan, vice president, Therapeutic Systems, said: "This study of the PMN cell collection protocol on the Spectra Optia system will garner another critical patient treatment option on a device built for choice and adaptability. Taking the steps necessary to advance additional procedures on our next-generation platform is critical in helping our customers touch the lives of very sick patients in need."
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