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Terumo obtains FDA 510(k) approval for Trima Accel to store platelets for seven days

Terumo BCT has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Trima Accel Automated Blood Collection System for a labeling change to extend the storage of platelets in plasma from five to seven days.

The approval has also granted for the Trima Accel system to offer wireless capability for the software applications, allowing to provide enhanced operational efficiencies and streamline workflows for blood centers.

Terumo BCT blood centers segment vice-president Greg Ballish said: "The seven-day platelet storage and wireless option designed for the Trima Accel system demonstrates our ongoing commitment to provide customers with a flexible platform, delivering the most blood component collection options to maximize a blood center’s operations and realize greater productivity — whether in fixed or mobile sites."

The platelet storage conditions will be verified for the standard Terumo BCT extended life platelet (ELP) storage bag for up to seven days post-collection in 100% plasma and up to five days in Isoplate Solution (PAS-F).

The clearance needs that every product must be tested with a bacterial detection device cleared by the FDA and labeled as a safety measure, for platelet storage up to seven days.

The wireless feature connects the Trima Accel system to key software applications, including Cadence Data Collection System and the Vista Information System, through the blood center’s or hospital’s existing wireless network.

This feature allows access to electronic donor information and reporting capabilities, helping to streamline collections, simplifying data management and allowing operators to focus on donor care, even when they are short of wired connection.