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15 JUL, 2014 - Health Canada Approves White Blood Cell Depletion and Polymorphonuclear Cell Collection Protocols on the Spectra Optia Apheresis System
7/15/2014

White blood cell depletions and polymorphonuclear cell collections on the next-generation therapeutic apheresis platform to provide procedure flexibility and intuitive operation

 

LAKEWOOD, Colo., July 15, 2014—Health Canada has approved the White Blood Cell Depletion (WBCD) protocol for clinical use on the Terumo BCT Spectra Optia® system. With this availability, clinicians in Canada now have the ability to perform WBCD procedures on the next-generation therapeutic apheresis system. In addition to the WBCD protocol, Health Canada also approved the polymorphonuclear (PMN) cell collection protocol, or granulocyte collections, adding to Spectra Optia system's versatility.

 

KEY FACTS ABOUT SPECTRA OPTIA SYSTEM AND THE WBCD PROTOCOL:

  • The goal of the WBCD procedure is the rapid removal of elevated numbers of white blood cells (WBCs) to reduce leukocytosis in patients suffering from blood cancers and other chronic diseases.
  • The Spectra Optia system's Automated Interface Management (AIM) system provides continuous interface monitoring, interpretation and adjustment for an efficient WBCD procedure.
  • The integrated system allows for fluid balance management without performing manual calculation.
  • The procedure's low packing factor and channel design allow for the separation of WBCs for an efficient WBCD procedure.

 

KEY FACTS ABOUT SPECTRA OPTIA SYSTEM AND THE PMN CELL COLLECTION PROTOCOL:

  • PMN cell collection approval by Health Canada follows a multi-site U.S. clinical trial that evaluated the Spectra Optia system's PMN cell collection protocol in 32 donors. The primary outcome measure was PMN cell collection efficiency, with secondary outcomes including measures of product volume, purity and PMN cell viability.
  • The PMN cell clinical trial results showed a mean collection efficiency of 53.7 percent ± 6.91 percent as compared to the COBE® Spectra Apheresis System's collection efficiency of 43.2 percent ± 6.23 percent.

 

KEY FACTS ABOUT SPECTRA OPTIA PROTOCOLS:

  • The WBCD and PMN cell collection protocols will be made available to customers in Canada with the installation of Software V11.
  • In Canada, the Spectra Optia system already offers red blood cell exchange (RBCX), therapeutic plasma exchange (TPE) with single- or dual-needle access, TPE with a secondary plasma device (SPD), mononuclear cell (MNC) collection and bone marrow processing (BMP) protocols.

 

KEY QUOTES:

Bob Sullivan, Terumo BCT, Vice President, Therapeutic Systems

"Further strengthening the existing portfolio of protocols available for use on the Spectra Optia system in Canada, the new white blood cell depletion and granulocyte collection protocols will provide more flexibility to the customers we serve. We are excited to deliver these added treatment options for the clinicians who advance apheresis every day in the delivery of exceptional patient care."

 

"The protocols now available on the Spectra Optia system in Canada represent the majority of total procedures performed on the original COBE Spectra system. These new protocol offerings add value for customers transitioning to the next-generation platform."

 

KEY RESOURCE: 

 

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. 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.

 

Contact:
Laura Fusco
Global Corporate Communications
Phone: +1.303.205.2546
press@terumobct.com