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Terumo BCT Receives FDA Approval

3 JAN, 2013 - Terumo BCT Receives FDA Approval to Conduct an Evaluation of its Polymorphonuclear Cell Collection Protocol

 

Clinical study to use Spectra Optia® Apheresis System for granulocyte collection

 

LAKEWOOD, Colo.-January 3, 2013-Terumo BCT has received approval from the U.S. Food and Drug Administration (FDA) to conduct a controlled evaluation of the polymorphonuclear (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.

 

KEY FACTS:

 ・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 U.S. 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 PMN cell collection protocol on the Spectra Optia system is already available in Europe, the Middle East, Australia and Africa.

・In the United States, the Spectra Optia system offers therapeutic plasma exchange (TPE) and mononuclear cell (MNC) collection protocols.

・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.