U.S. Food and Drug Administration Clears Granulocyte Collection Procedure on the Spectra Optia Apheresis System

Granulocyte, or polymorphonuclear [PMN] cell, collections on the next-generation therapeutic apheresis platform to optimize cellular collections and supplement current protocol offering

LAKEWOOD, Colo.--January 28, 2014--The FDA recently cleared the PMN protocol for clinical use on the Terumo BCT Spectra Optia system . With this availability, clinicians now have the ability to perform PMN collections with greater choice and flexibility to customize each procedure. This news follows recent Terumo BCT announcements regarding FDA clearance of the red blood cell exchange (RBCX) protocol and therapeutic plasma exchange (TPE) with single-needle access on the Spectra Optia system.

The FDA clearance was received following a premarket notification file review which included U.S. PMN clinical trial data.

U.S. Clinical Trial - Patient Study

• A multi-site U.S. clinical trial was conducted to evaluate the Spectra Optia system's PMN collection protocol in granulocyte colony-stimulating factor (GCSF) and dexamethasone-mobilized donors.
• Thirty-two healthy adult volunteers from three investigational sites participated in a pivotal crossover study designed to benchmark system performance against the COBE ® Spectra Apheresis System.
• The primary outcome measure was PMN collection efficiency, with secondary outcomes including measures of product volume, purity and PMN viability.
• Clinical trial results demonstrated that the Spectra Optia system is able to collect granulocytes efficiently and, also, that the new protocol is platelet sparing and preserves granulocyte viability throughout the collection process. Mean collection efficiency for the 32 granulocyte collections was 53.7 percent +/- 6.91 percent as compared to the COBE Spectra system's collection efficiency of 43.2 percent ± 6.23 percent.

Key Facts:

• In patients who have developed severe infections and are at a higher risk of mortality, transfused PMN cells may help fight the infe ction until the patient's immune system is restored.
• In the U.S., the Spectra Optia system already offers RBCX, TPE with single- or dual-needle access and mononuclear cell (MNC) collection protocols.
• The Spectra Optia system already offers RBCX, TPE with single- or dual-needle access, TPE with a secondary plasma device, MNC and bone marrow processing (BMP) protocols in Canada.
• The Spectra Optia system offers nine protocols in Europe, Australia, Africa, the Middle East and select areas of Asia, including: MNC, RBCX, TPE with single- or dual-needle access, TPE with a secondary plasma device, granulocyte collections, BMP, white blood cell depletions and platelet depletions.

Key Quotes:

"Terumo BCT is pleased to have received clearance for the PMN procedure on the Spectra Optia system--which we believe will benefit patients and clinicians across the U.S. As the very latest protocol cleared by FDA for patient care on the next-generation Spectra Optia system, we are thrilled to now give caregivers an even broader range of options for advancing therapeutic apheresis and cell collections using the Spectra Optia system."

Key Resource:

• Spectra Optia System Fact Sheet

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.