The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo BCT's automated blood collection system, designed for collecting and storing platelets in Isoplate platelet additive solution (PAS).
The solution, which replaces a portion of the plasma in blood products, has been shown to store platelets collected on the Trima system for up to five days in clinical studies.
The device, Trima Accel, features a new disposable tubing sets that facilitate the addition of Isoplate to platelets, software modifications that enable automated metering of the appropriate volume of PAS.
Automated features are also embedded in the device for tracking product volumes and blood loss per donation.
The company said plasma replaced by PAS can be collected as an additional plasma product for transfusion, while still classifying the donors for plateletpheresis for deferral purposes.
Subsequent to the 510(k), the FDA approved the new drug application (NDA) submitted by B. Braun Medical for Isoplate as a PAS solution for platelets collected on the automated platform.
Terumo BCT Blood Center Segment global geographic marketing vice president Teri Motheral said, "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."
