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FDA Clears Bone Marrow Processing Protocol on Terumo BCT Spectra Optia® Apheresis System, an Additional Submission for the Device is Under Review

5/6/2015

LAKEWOOD, Colo., USA—6 May 2015—The U.S. Food and Drug Administration (FDA) cleared the bone marrow processing (BMP) protocol for the Terumo BCT Spectra Optia® Apheresis System in March 2015. A separate submission to gain clearance for a continuous mononuclear cell collection (CMNC) protocol is under review. With the BMP clearance, there are now five protocols available for cell collection and therapeutic apheresis on the Spectra Optia system in the U.S.

The Spectra Optia system can perform BMP procedures in less than 90 minutes. The CMNC protocol, which has been submitted to the FDA, is designed to collect mononuclear cells (MNCs) including monocytes, lymphocytes, CD34+ and dendritic cells in customizable, single-stage processing.

KEY FACTS:

  • The Spectra Optia system is a therapeutic apheresis and cell collection platform with on-screen instructions to guide operators through setup, monitoring and adjustments, allowing operators to focus  on patient care

  • Protocols available on the Spectra Optia system in the U.S. include BMP, mononuclear cell collection (MNC), granulocyte (PMN) collection, therapeutic plasma exchange (TPE)―also available with single-needle access―and red blood cell exchange (RBCX)

BMP protocol:

  • The FDA cleared the BMP protocol with the Spectra Optia system in March 2015 under 510(k) number BK140191

  • The Spectra Optia system performs BMP procedures with precision including red blood cell reduction greater than 97 percent, volume reduction greater than 90 percent and final product volume less than 200 mL[1]

CMNC protocol:

  • Terumo BCT filed a premarket notification application, or a 510(k) submission, to the FDA for this protocol on the Spectra Optia system in April 2015

  • The protocol is designed to allow the collection of MNCs including monocytes, lymphocytes, CD34+ and dendritic cells in single-stage processing

  • The protocol is designed to enable operators to specify how much plasma to collect into their plasma bag or collection bag, control inlet flow rate, collect pump flow rate, packing factor and collection preference

KEY QUOTES:

Bob Sullivan, Vice President, Therapeutics, Terumo BCT
"The Spectra Optia system gives clinical facilities treatment flexibility and allows them to focus on patient care. With the new BMP protocol available in the U.S., it's an ideal time for customers to consider this next-generation device from its predecessor, the COBE® Spectra Apheresis System."

KEY RESOURCES:

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.

Media Contact
Sherri Hughes-Smith, Terumo BCT Global Integrated Communications
Phone: 303.542.5113
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[1] Data on file


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