IMUGARD WB PLT Platelet Pooling Set

2/14/2023

IMUGARD to help strained U.S. platelet supply meet growing need

Today, Terumo Blood and Cell Technologies announce U.S. 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.¹ IMUGARD is the first platelet pooling set approved for seven-day storage in the U.S. 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 a component of human blood that form clots and stop bleeding. They 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 U.S., 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.¹ This can help blood centers better manage supply to meet patient needs and reduce waste.^2,3 Most of the platelets in the United States are currently collected by apheresis. IMUGARD now gives blood centers another product choice to help them recoup platelets from whole blood donations.

1. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. December 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bacterial-risk-control-strategies-blood-collection-establishments-and-transfusion-services-enhance. Accessed October 3, 2023. 
2. Delage G, Bernier F, Beaudoin J, Thibault S, Dion J, Gagné L. Improved bacterial culture of platelet product: preliminary results after implementation of a two-bottle system with 48-hour sampling. Transfusion. 2016:56(S4);28A. 
3. Harm SK, Szczepiorkowski ZM, Dunbar NM. Routine use of Day 6 and Day 7 platelets with rapid testing: two hospitals assess impact 1 year after implementation. Transfusion. 2018;58(4):938-942.

The IMUGARD WB PLT Platelet Pooling Set is intended to be used to leukocyte-reduce, pool, and store whole blood-derived platelets. For platelets prepared through manual methods, leukoreduction and pooling occur on Day 1, the day after whole blood collection and processing, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. For platelets prepared by the Reveos™ Automated Blood Processing System, leukoreduction and pooling occur on Day 1 or Day 2, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. Additionally, for platelet units stored past 5 days and through 7 days, every pooled platelet product must be tested with a bacterial detection device cleared by FDA and labeled as a "safety measure."