Terumo receives FDA clearance for automated whole blood processing system

Dive Brief:

• Terumo Blood and Cell Technologies received clearance from the Food and Drug Administration for what it claims is the first whole blood automation device available in the U.S. 
• The Reveos Automated Whole Blood System processes blood into platelets and other components in a single centrifugation cycle, eliminating some manual steps to separate platelets from the rest of the blood. 
• The device can help blood centers make the process of collecting platelets from blood donations more efficient, increasing availability for people who need them for treatment, Chetan Makam, general manager of Terumo’s global blood solutions business, said in an interview.

Dive Insight:

Platelets are used to treat trauma patients, for procedures like heart surgeries, and for patients who are undergoing chemotherapy. Demand for platelets continues to increase, Makam said.

Currently, the majority of platelets available for transfusion in the U.S. come from a process called apheresis, where a donor’s blood is drawn, some components are isolated from it, and the rest of the blood is returned back to the donor. Donations through apheresis are not expected to keep up with the demand for platelets, and some older donors can’t donate through this method anymore, Makam said. 

“We are adjusting to the demographic changes in the blood donation population as well,” Makam said. “We would love to see the percentage of people who donate increase.” 

The company hopes that its newly cleared device will help solve this problem by making the process of separating blood into its individual components more efficient for blood centers, and improving the platelet supply for patients. 

Currently, the process of separating whole blood into components can take up to 18 or 20 manual steps. The Reveos device can reduce that process down to five or seven steps, depending on the center, Makam said. 

To start, Terumo is partnering with Blood Centers of America, the largest blood supply network in the U.S., to deploy the new devices. 

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

As part of the Reveos clearance, Terumo also obtained an intended use statement for its Imugard WB Platelet Pooling Set, which can extend the shelf life of platelets from five days to seven days.