FDA Clearance of Terumo’s Blood Collection And Storage System Means Plasma Goes Further

In short

Terumo BCT has gained 510(k) clearance from the U.S. FDA to collect platelets on the Trima Accel system for storage in Isoplate platelet additive solution (PAS), which replaces a portion of the plasma in blood products.

This means that blood centers in the United States can now collect platelets on the Trima Accel system in 65 percent less plasma volume and store platelets in Isoplate for up to five days, which reduces the single-donor plasma volume in the transfused platelet product.

Background

Platelets are transfused to help prevent or stop bleeding, and are most commonly used in patients undergoing chemotherapy and in cases of trauma. Due to the five-day shelf life, platelets are in constant demand.

Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies. It is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing.

Clinical studies demonstrate that the Isoplate PAS formulation supports storage of platelets collected on the Trima Accel system for up to five days. The Trima Accel system now includes new disposable tubing sets that facilitate the addition of Isoplate to platelets, software modifications that enable automated metering of the appropriate volume of PAS and improved traceability with automated tracking of product volumes and blood loss per donation. Furthermore it can automatically calculate the volume of plasma replaced by PAS which can then be collected as an additional plasma product for transfusion, while still classifying the donors for plateletpheresis for deferral purposes.

Terumo’s PAS-stored platelets mean that any blood product collected in any combination can be stored on a the company’s Trima Accel platform.

Subsequent to the 510(k) clearance, the FDA approved the New Drug Application (NDA) submitted by B. Braun Medical for Isoplate as a PAS solution for platelets collected on the Trima Accel system. The NDA was subsequently transferred from B. Braun to Terumo BCT who now owns both the device and the solution

Company comments

Teri Motheral, Vice President, Global Geographic Marketing, Blood Center Segment said; “This is a great achievement. Our technology offers many benefits. With the inclusion of the PAS product offering on the Trima Accel system, we are able to help our customers enhance their productivity while delivering beneficial care to patients.”

Source: Terumo BCT, Business Wire