FDA Clears Terumo's Reveos® Automated Whole Blood Processing System for U.S. Commercial Use

02 August 2023 | Wednesday | News

Reveos is positioned to help U.S. blood centers supplement the platelet supply, reduce labor and costs, and improve overall operational efficiency

Terumo Blood and Cell Technologies (Terumo BCT) announces U.S. Food and Drug Administration (FDA) clearance of the Reveos Automated Whole Blood Processing System, the first whole blood automation device available in the U.S. that processes whole blood into platelets and other components in a single centrifugation cycle. Automated processing of whole blood on the Reveos system, the only device of its kind globally, will enhance the blood and platelet supply for patients in the U.S.

Terumo Blood and Cell Technologies' Reveos is the first and only system of its kind, now cleared by FDA for the U.S. It aims to help U.S. blood centers supplement the platelet supply, reduce labor and costs, and improve overall operational efficiencies.

Platelets are used to treat patients with many conditions, including trauma and cancer. Today, 94% of platelets available for transfusion in the U.S. come from apheresis,[1] a process that draws a donor's blood, isolates desired components from it, and returns the rest of the blood to the donor, using platforms such as Terumo BCT's Trima Accel® Automated Blood Collection System.

Apheresis donations are not projected to keep up with increases in platelet usage.[2] FDA's clearance of the automated Reveos system gives blood centers the added capacity to collect platelets from existing whole blood donations efficiently.

In Reveos, Terumo BCT brings to the U.S. a platform with an established track record following deployment in 52 countries over the past decade. Reveos is the only automated device to process whole blood into platelets, plasma and red blood cell (RBC) components in a single centrifugation cycle.

Terumo BCT continues making investments to support blood centers. In 2022, FDA cleared its IMUGARD WB Platelet Pooling Set, which supports the extended shelf life of platelets from five days to seven days. As part of the Reveos clearance, Terumo BCT obtained an intended use statement for the IMUGARD WB Platelet Pooling Set that includes platelets prepared by Reveos; these platelets can be pooled on day one or day two after collection — providing even more flexibility to blood centers using Reveos.

"Reveos will help blood centers maximize the use of whole blood donations while increasing the availability of platelets for patients in need," said Bill Block, President and CEO of Blood Centers of America, the largest blood supply network in the U.S. "We look forward to deploying this technology within our membership and at our blood center partners across the country later this year."

By automating whole blood processing, Reveos can reduce the working hours needed by laboratory staff by up to 30%.[3] Whole blood is collected from donors and has traditionally been separated into components using manual methods that take as many as 18 or 20 steps. Reveos simplifies this process and eliminates over half the steps.4

"Reveos has a long-standing track record for helping blood centers globally meet the critical needs of patients while creating efficiencies in their operations," said Antoinette Gawin, President and CEO of Terumo BCT. "We continue to invest significantly in innovation for the future and in supporting blood centers. Reveos and IMUGARD together target the growing and critical need for platelets. These are just more examples of our holistic work supporting blood centers."

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