Delivering Leukoreduced Whole Blood Platelets for Storage up to Seven Days*

The IMUGARD WB PLT Platelet Pooling Set delivers prestorage pooled and leukoreduced whole blood-derived platelet (PLT) products for storage up to seven days when used with bacterial detection tests cleared or approved by the U.S. Food and Drug Administration (FDA).*

IMUGARD WB PLT is the first whole blood-derived 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 and the supply remains challenged by a lack of blood donors.

Delivering Leukoreduced Whole Blood Platelets for Storage up to Seven Days*

Discover the Benefits and Features

The set is designed to extend whole blood platelet shelf life, help blood centers better manage supply to meet patient needs, and reduce waste. ^1,2

Leukoreduction

Highly specific pore size and distribution enable consistent, efficient filtration of leukocytes.

Reduced Platelet Loss

The filter’s small priming volume of 17 mL allows you to retain more platelets in your final product.

Biocompatibility

The filter is made from microporous polyurethane and manufactured in accordance with international standards for material biocompatibility.

IMUGARD WB PLT Platelet Pooling Set

Pooling Tubes +

Used to sterile-connect up to six whole blood platelet bags.

IMUGARD WB PLT Leukoreduction Filter +

Made from microporous polyurethane, with highly specific pore size and distribution, used to leukoreduce the pooled platelets.

ELP Platelet Storage Bag +

The same storage bag used since 1985 to store apheresis platelets.

Sampler and Air Transfer Bag +

Pre-attached sampler used to take final product quality control samples.

Contact your Terumo Blood and Cell Technologies representative for details about the IMUGARD WB PLT Platelet Pooling Set today.

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Performance Data

	Filtration Duration (m:sec)	Platelet Recovery (%)	rWBC Content (×10⁶) per Unit	Volume, as Stored (mL)	Platelet Yield, as Stored (×10³ per µL)	As Stored (×10¹¹ per µL)	pH^22°C Day 7
Mean ± SD	22:56 ± 03:37	88.5 ± 2.8	0.27 ± 0.23	239.6 ± 35.1	1600 ± 156	3.83 ± 0.63	7.06 ± 0.16
Range	16:17-28:56	79.6-92.3	0.02-1.26	187.8-334.1	1099-2045	2.53-5.07	6.30-7.33
N	69	68	87	87	87	87	83

Note: 53.6% (37/69 pools) had 4 units per pool; the remainder had 5 units per pool.
N: sample size; rWBC: residual white blood cell; SD: standard deviation; m: minutes; sec: seconds.
Source: Data on file at Terumo Blood and Cell Technologies. Data collected in U.S. clinical study.

News Release

2/14/2023

IMUGARD to Help Strained U.S. Platelet Supply Meet Growing Need

Today, Terumo Blood and Cell Technologies announces 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.

"We continue to invest in innovations that help blood centers to positively impact patients. IMUGARD opens the possibility for U.S. blood centers 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 U.S., adding flexibility to the platelet supply. This is especially important now with the increased demand for platelets and the challenges blood centers face with recruiting new apheresis platelet donors."
― Chetan Makam, General Manager, Global Blood Solutions, Terumo Blood and Cell Technologies

¹U.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.
²Delage 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.
³Harm 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.

Intended Use Statement

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."

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References

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.
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.

^*Notes

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."

The IMUGARD WB PLT Platelet Pooling Set is available in the United States. Please contact your Terumo Blood and Cell Technologies representative for availability. Availability is subject to the local authority’s approval.

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