Terumo Medical Corp. Receives FDA Clearance for TSCD® II/Trucise® Data Management System

Next-Generation Welder and Data Management System Now Available in the United States from Terumo BCT

LAKEWOOD, Colo.--(BUSINESS WIRE)-- The U.S. Food and Drug Administration (FDA) has cleared Terumo Medical Corp.’s TSCD II/Trucise Data Management System for use in the United States. The TSCD II/Trucise system provides consistent, flexible and sterile tubing connections, in a functionally closed system, including wet-to-wet tubing connection capabilities and the added benefit of an automated data entry and process control system on a range of Microsoft® Windows® platforms.

KEY FACTS:

• The TSCD II with the optional Trucise system is a Class II medical device used to connect two closed sterile components such as a blood collection container, apheresis set, transfer set or needle set, by making a sterile weld in the PVC tubing connected to these components.
• Welds made by the TSCD II system may consist of wet-to-wet, dry-to-dry or wet-to-dry connections. The resulting sterile component may be used in blood collection, blood component processing or transfusion applications.
• The TSCD II system guides operators through the welding process with sensors that alert the user when to replace the wafer cartridge and when to empty the wafer disposal box. Its simplified clamp configuration provides greater operational efficiency and less opportunity for human error.
• Ideal for both in-center and mobile blood drives, the TSCD II system is lightweight, compact and features a pop-up handle for easy system transport.
• The TSCD II is compatible with the Trucise system V2.0, which combines a communications module, barcode scanner and application software to electronically collect information and provide traceability of each sterile connection made by the welder.
• Now compatible with Windows® 7, Windows® XP and Vista, the Trucise system minimizes user error with an easy-to-use touch screen, and provides accurate and efficient data entry.
• The TSCD II/Trucise system serves customers throughout the U.S., helping improve efficiency and reduce risks associated with lab processes.
• The TSCD II/Trucise system was developed to help blood centers and hospitals advance their operations and management by: reducing processing costs; increasing system and product efficiencies; and offering improved quality and regulatory compliance.

KEY QUOTES:

Teri Motheral, Terumo BCT Vice President, Global Geographic Marketing, Blood Center Segment

“Clearance of the TSCD II/Trucise system for use in the U.S. gives blood centers and hospitals access to a critical resource that can help them reduce costs and streamline laboratory operations. The TSCD II/Trucise system provides the versatility that cost-conscious blood centers need, and that hospitals seeking high quality and regulatory compliance require. It is the technology of choice when it comes to sterile welding flexibility.”

KEY RESOURCES:

• FDA 510(k) Clearance 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.

Terumo BCT
Laura Fusco
Global Corporate Communications
Phone: [phone]
[e-mail]

Source: Terumo BCT