FDA clearance would offer clinicians more options for patient care
LAKEWOOD, Colo., USA—October 2, 2015—Terumo BCT filed a premarket authorization 510(k) submission for the Platelet Depletion (PLTD) and White Blood Cell Depletion (WBCD) protocols, two key developments intended to advance flexibility and treatment options on the Spectra Optia® Apheresis System. These two protocols can help treat a variety of medical conditions resulting from high white blood cell or platelet counts.
FDA clearance for the PLTD and WBCD protocols would provide additional patient treatment options to clinicians using the Spectra Optia system.
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The PLTD protocol is designed to reduce the number of platelets in patients with high platelet levels
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The WBCD protocol is designed to reduce the number of white blood cells in patients with high white blood cell levels
"Continuous development of the Spectra Optia system can help our customers treat their patients suffering from conditions caused by high platelet or white blood cell levels. Our recent protocol submission demonstrates our commitment to grow the value of our portfolio," said Bob Sullivan, Vice President of Therapeutics, Terumo BCT. "By adding new protocols in the U.S., we would offer exciting benefits to customers who move to the evolving Spectra Optia system from its predecessor, the COBE® Spectra Apheresis System."
KEY FACTS:
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Terumo BCT submitted a 510(k) premarket application to the FDA for PLTD and WBCD protocols for the Spectra Optia system
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As Terumo BCT works to advance the Spectra Optia system, the company will no longer support its predecessor, the COBE Spectra system, in the U.S. after December 31, 2017
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.
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