LAKEWOOD, Colo.--(BUSINESS WIRE)-- Terumo BCT has received 510(k) clearance from the U.S. Food and Drug Administration (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. 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.
Clinical studies demonstrate that the Isoplate formulation supports storage of platelets collected on the Trima Accel system for up to five days
To accommodate platelets stored in Isoplate, 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
Improved traceability with automated tracking of product volumes and blood loss per donation
Automated calculation of plasma replaced by PAS
Plasma replaced by PAS can be collected as an additional plasma product for transfusion, while still classifying the donors for plateletpheresis for deferral purposes
PAS-stored platelets support the collection of any blood product in any combination on a single platform, the Trima Accel system
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 transferred from B. Braun to Terumo BCT who now owns both the device and the solution
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.
Teri Motheral, Vice President, Global Geographic Marketing, Blood Center Segment
“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.”
NDA approval letter
About Terumo BCT:
Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, 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. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
D. Nikki Wheeler, +1-303-205-2828
Global Corporate Communications