LAKEWOOD – Terumo BCT, a leader in blood component, therapeutic apheresis and cellular technologies, has received approval from the U.S. Food and Drug Administration to conduct a controlled evaluation of the polymorphonuclear (PMN) cell collection protocol on its next-generation apheresis platform called the Spectra Optia system, the company announced.
Donor PMN cells 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, Terumo said.
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, the company said.
The evaluations will be held at up to four unidentified U.S. sites. The PMN cell collection protocol on the Spectra Optia system is already available in Europe, the Middle East, Australia and Africa.
“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,” said Bob Sullivan, Therapeutic Systems vice president.
“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.”
For more information, visit www.terumobct.com.