Terumo's automated blood processing system snags FDA clearance to boost US platelet supply

The recent blood shortage in the U.S.—exacerbated by the COVID-19 pandemic and a plummeting number of donations—has had a particularly strong effect on the growing demand for platelets, which help stop bleeding and can aid in the treatment of blood cancers, cardiac surgeries and other intensive-care needs.

Platelet usage is increasing, but supply is low, since there are limited ways to extract the clot-creating components. Currently, they’re almost always obtained via apheresis procedures, where a machine separates out the platelets from a blood sample and returns the rest back to the donor.

With those apheresis donations expected to fall well short of demand, the FDA has greenlighted a solution: a machine from Terumo Blood and Cell Technologies that can separate out platelets and other components from previously collected whole-blood samples rather than relying on real-time apheresis procedures.

Terumo Reveos

Terumo’s Reveos system automates the entire blood-processing procedure. In a single centrifugation cycle, it can separate up to four whole-blood samples into platelets, plasma and red blood cells—a process that can take 30% more time and requires a long list of steps when done manually.

The automated machine is the first of its kind, according to its maker. Outside the U.S., Terumo has already rolled out the Reveos system across dozens of countries throughout the last decade.

“Reveos has a long-standing track record for helping blood centers globally meet the critical needs of patients while creating efficiencies in their operations,” Antoinette Gawin, Terumo’s president and CEO, said in a company announcement Tuesday.

With its new FDA clearance, the system can now be used by blood donation centers in the U.S. to easily extract needed components from existing blood stores, which the company said could significantly improve the country’s blood and platelet supply.

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

Reveos’ FDA clearance comes not long after Terumo snagged another nod from the agency for platelet-focused technology. In that case, last year, the FDA cleared the IMUGARD WB Platelet Pooling Set, which helps extend the shelf life of platelets from five days to up to a week.

The Reveos clearance came with an FDA green light allowing platelets separated out by the machine to be pooled using the IMUGARD set within a day or two of collection.

“We continue to invest significantly in innovation for the future and in supporting blood centers,” Gawin said in Tuesday’s release. “Reveos and IMUGARD together target the growing and critical need for platelets. These are just more examples of our holistic work supporting blood centers.”