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FDA clears SN-TPE on Terumo system, 11/13

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Terumo BCT has received FDA 510(k) clearance for single-needle therapeutic plasma exchange (SN-TPE) on its Spectra Optia apheresis system. This option gives therapeutic apheresis operators the ability to convert to SN-TPE at the beginning or at any time during the procedure, depending on patient needs.

In the U.S., the Spectra Optia system offers TPE and mononuclear cell (MNC) collection protocols. In Canada, the system offers TPE, MNC, and red blood cell exchange protocols. Additional protocols are offered in Europe, Australia, Africa, the Middle East, and select areas of Asia.

Terumo BCT, 877-339-4228

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