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Terumo’s IMUGARD Platelet Pooling Set cleared by FDA

Terumo Blood and Cell Technologies has announced US Food and Drug Administration (FDA) clearance and official launch of its IMUGARD WB Platelet Pooling Set, which supports extended shelf life of whole blood-derived platelets from five days to seven days.

IMUGARD is the first platelet pooling set approved for seven-day storage in the US and provides an alternate source of platelet supply at a time when demand continues to increase while the supply remains challenged by the lack of blood donors.

Terumo Blood and Cell Technologies is a medical technology company that makes products that collect, process and separate blood and cells. Platelets are used to treat many different patients, such as those undergoing chemotherapy, organ transplants and bone marrow transplants. In 2021, more than 2.5 million units of platelets were transfused in the US, up from 2.3 million in 2019, according to the National Blood Collection and Utilization Survey (NBCUS).

Terumo Blood and Cell Technologies’ latest innovation aims to increase the availability of platelets for transfusion. IMUGARD enables extended shelf life of platelets from the standard five days to seven days. This can help blood centres better manage supply to meet patient needs and reduce waste.

Most of the platelets in the United States are currently collected by apheresis. IMUGARD now gives blood centres another product choice to help them recoup platelets from whole blood donations.

“We continue to invest in innovations that help blood centres to positively impact patients,” says Chetan Makam, General Manager, Global Blood Solutions, Terumo Blood and Cell Technologies. “IMUGARD opens the possibility for US blood centres to use the platelets from their whole blood donations to increase the number of platelets available for transfusion. We are the first company to provide seven-day shelf life of both apheresis and whole blood-derived platelets in the US, adding flexibility to the platelet supply. This is especially important now with the increased demand for platelets and the challenges blood centres face with recruiting new apheresis platelet donors.”

 

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