FDA Approves Terumo’s Reveos System: Automated Whole Blood Processing to Address Platelet Shortage

Terumo Blood and Cell Technologies have introduced the Reveos system, an automated blood-processing machine designed to separate platelets and other components from previously collected whole-blood samples.

The United States is experiencing an increasing demand for platelets, which are crucial for treating blood cancers, cardiac surgeries, and other intensive-care needs. This demand is not being fully met due to various factors such as the COVID-19 pandemic and a decline in blood donations. The current method of obtaining platelets through apheresis procedures, where platelets are separated from a blood sample and the rest is returned to the donor, is proving inadequate to meet the growing need.

Terumo’s technology aims to address this issue by eliminating the reliance on real-time apheresis procedures and streamlining the process of extracting platelets, plasma, and red blood cells from up to four whole-blood samples in a single centrifugation cycle. Compared to manual methods, Reveos significantly reduces processing time by up to 30%, thereby reducing the extensive list of steps involved.

The Reveos system has already been successful in numerous countries outside the U.S., helping blood centers to meet critical patient needs while optimizing their operations. Recently, Terumo received FDA clearance for Reveos to be used by blood donation centers across the United States. This approval enables blood centers to extract necessary components from existing blood stores, offering a promising solution to enhance the nation’s blood and platelet supply.

The introduction of Reveos promises to be beneficial for blood centers as it maximizes the utilization of whole blood donations and increases the availability of platelets. Terumo’s president and CEO, Antoinette Gawin, expressed enthusiasm about the potential impact of Reveos in fulfilling the rising demand for platelets. Terumo has partnered with Blood Centers of America, the largest blood supply network in the U.S., to deploy the Reveos system within their membership and nationwide later this year.

It is important to note that the FDA clearance for Reveos coincides with another FDA approval for Terumo’s platelet-focused technology—the IMUGARD WB Platelet Pooling Set. This set extends the shelf life of platelets from five days to seven days, further supporting the goal of maintaining an adequate supply of this vital blood component.

Presently, the process of manually separating whole blood into its individual components involves an intricate series of 18 to 20 steps. Reveos simplifies this process, reducing it to five or seven steps depending on the center, resulting in enhanced efficiency and reliability. Terumo’s vision involves addressing the demographic changes in the blood donation population by inspiring more people to donate.

Through collaboration with Blood Centers of America, Terumo aims to optimize the process of blood component separation, alleviate the platelet shortage, and provide an efficient solution for blood centers. The Reveos system, in tandem with the IMUGARD WB Platelet Pooling Set, offers a comprehensive approach to meet the critical need for platelets in various medical treatments. Terumo remains dedicated to investing in future innovations and supporting blood centers to ensure a stable and abundant blood supply for patients in need. With these advancements, the prospect of alleviating the platelet shortage and meeting the growing demand for life-saving treatments appears promising.

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