FDAnews
www.fdanews.com/articles/172561-terumo-bct-gets-fda-approval-for-longer-platelet-storage
ApprovedGreen.gif

Terumo BCT Gets FDA Approval for Longer Platelet Storage

August 11, 2015

Terumo BCT has received 510(k) clearance from the FDA to extend the storage of platelets in plasma from five days to seven using the company’s Trima Accel automated blood collection system.

The system also offers wireless capability for software applications, enabling access to electronic donor information and reporting capabilities that can streamline collections and simplify data management.

The extended storage for platelets will help blood centers better meet the changing needs at hospitals, Terumo says. For platelet storage up to seven days, the clearance requires that every product be tested with a bacterial detection device cleared by the FDA.

The Lakewood, Colo., company focuses on blood component, therapeutic apheresis and cellular technologies. — John Bechtel