Granulocyte, or polymorphonuclear [PMN] cell, collections on the next-generation therapeutic apheresis platform to optimize cellular collections and supplement current protocol offering
LAKEWOOD, Colo., USA—28 January 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
Bob Sullivan, Vice President of Therapeutic Systems Worldwide Sales and Marketing "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."
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 technologies. 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.
Sherri Hughes-Smith, Terumo BCT Global Integrated Communications
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