U.S. Food and Drug Administration Clears Sickle Cell Disease Indication with New Red Blood Cell Exchange (RBCX) Protocol on the Spectra Optia® Apheresis System in the United States
LAKEWOOD, Colo.--(BUSINESS WIRE)--Terumo BCT has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for RBCX on the Spectra Optia Apheresis System. This option gives clinicians the flexibility to perform multiple types of RBCX procedures on the Spectra Optia system, and tailor each procedure for the transfusion management of sickle cell disease in adults and children.
KEY FACTS ABOUT RBCX ON SPECTRA OPTIA SYSTEM:
With the addition of the RBCX capability, the Spectra Optia system can now perform three dedicated procedures—exchange, depletion and depletion/exchange
The RBCX procedure on the Spectra Optia system delivers enhanced procedural flexibility as compared to the same procedure on the COBE® Spectra Apheresis System
Results of a U.S. clinical trial concluded that RBCX on the Spectra Optia system enables clinicians to safely and effectively treat adults and children with sickle cell disease:
The study confirmed that the Spectra Optia system decreased the percentage of hemoglobin S in patients, as expected, for the amount of replacement red blood cells administered
Study results included a post-procedure patient hematocrit within 1.03% (standard deviation of 0.065%) of that targeted by the Spectra Optia system
The clinical trial was the first RBCX FDA 510(k)-supporting study to include pediatric patients
In the U.S., the Spectra Optia system now offers RBCX, therapeutic plasma exchange (TPE) with single or dual-needle access and mononuclear cell (MNC) collection protocols
The RBCX protocol on the Spectra Optia system has been available in Canada since May 2010 and available since November 2009 in Europe, Australia, and in select countries in the Middle East and Africa
The Spectra Optia system offers nine protocols in Europe, Australia, Africa, the Middle East and select areas of Asia, including: RBCX, MNC, TPE with single or dual-needle access, TPE with a secondary plasma device, granulocyte collections, BMP, white blood cell depletions and platelet depletions
KEY FACTS ABOUT SICKLE CELL DISEASE
More than 100,000 people suffer from sickle cell disease in the United States, according to the Centers for Disease Control and Prevention
In patients with sickle cell disease, the abnormal hemoglobin (hemoglobin S) in the cells sticks together when oxygen is released to the tissues, causing clumping that forces red cells to become stiff and sickle shaped
Patients with sickle cell disease often experience pain, fatigue and difficulty breathing, among other symptoms
Sickle cell disease can lead to stroke; damage to the heart, kidneys, liver and lung tissue; anemia; and serious infections
KEY QUOTES:
Bob Sullivan, Vice President of Therapeutic Systems Worldwide Sales and Marketing
“The launch of the RBC exchange protocol in the U.S. empowers our customers to use the Spectra Optia Apheresis System, the next-generation apheresis system, to perform RBCX procedures for the transfusion management of sickle cell disease in adults and children.”
“Terumo BCT is thrilled to have collaborated with Dr. Haewon Kim of Children’s Hospital in Philadelphia to develop the dedicated RBC depletion/exchange procedure concept. This capability on the Spectra Optia system helps clinicians make a difference in the lives of adults and children with sickle cell disease.”
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 customer.
Contacts
Terumo BCT
Laura Fusco, +1-303-205-2546
Global Corporate Communications
press@terumobct.com
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