Terumo BCT receives FDA clearance to collect platelets on Trima Accel system

Published on April 10, 2013 at 7:49 AM · 1 Comment

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.

“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.”

KEY FACTS:

  • 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.

KEY QUOTES:

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."

Source:

Terumo BCT

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Comments
  1. David Gremillion David Gremillion United States says:

    I wonder if the AABB will consider apheresis platelets manufuctured using this technology a TRALI low risk product similar to whole blood derived platelet concentrates?

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