BRUSSELS, Belgium—March 31, 2010— CaridianBCT, a leading global provider of technology, products and services in the blood banking, transfusion medicine and cell therapy industries, today announced that a panel of medical and scientific experts have endorsed the effectiveness of the Mirasol® Pathogen Reduction Technology (PRT) System for replacing gamma irradiation, the current standard of care for preventing transfusion-related Graft vs. Host Disease (GVHD) in platelet recipients. GVHD is an infrequent but often fatal complication associated with transfusion of cellular blood components in patients with suppressed immune systems.
The Mirasol PRT system's demonstrated ability to irreversibly inactivate residual white blood cells forms the basis of this new claim. "There is clear and convincing evidence that the Mirasol PRT system effectively prevents replication of white blood cells known to cause GVHD in patients at risk," said Dr. Paul D. Mintz, professor of Pathology and Medicine and director of Clinical Laboratories and Transfusion Services at University of Virginia Health System. " Given the safety, security and logistical issues associated with gamma irradiation, the Mirasol PRT system offers an innovative and convenient means for avoiding this highly fatal risk of platelet transfusion. This benefit is in addition to the broad pathogen reduction achieved with this system."
The Mirasol PRT system uses the unique properties of riboflavin (vitamin B2), a naturally occurring compound, and ultraviolet light to inactivate disease-causing agents including viruses, bacteria, parasites and white blood cells that may be present in blood components for transfusion.
The gamma irradiation equivalency claim, further supported by other independent experts, is the first element in a patent granted to CaridianBCT for preventing transfusion-related complications caused by viable white blood cells in donated blood components.
"Providing blood centers and physicians with the means to enhance the treatment of patients is what drives our passion and commitment to improving the safety of the blood supply," said Teresa Ayers, senior vice president of the Pathogen Reduction Technologies division at CaridianBCT.
Currently in routine use in nine countries throughout Europe, the Middle East and Africa, over 40,000 Mirasol PRT treatment sets have been distributed for pathogen reduction of both platelet and plasma products. Post-market surveillance on over 2,000 transfusions of Mirasol-treated platelet products has shown no device-related adverse events, confirming the safety of these products in routine clinical use. In addition, several clinical trials and active post-market surveillance activities are being conducted to further demonstrate the safety and clinical effectiveness of Mirasol-treated platelet and plasma products.
About the Mirasol PRT System
The only device on the market to use a combination of riboflavin (vitamin B2), a non-toxic naturally occurring compound, and ultraviolet light, the Mirasol PRT system delivers immediately transfusable blood products, enabling blood centers to release pathogen reduced blood products for timely patient care.
CaridianBCT received a CE Mark for the Mirasol PRT system in 2007 for treating platelets suspended in plasma. A subsequent CE mark was granted in 2008 for treating fresh frozen plasma (FFP) and for treating plasma-reduced platelet concentrates that are subsequently stored in Platelet Additive Solution. The Mirasol PRT system is available for sale in countries where the CE mark is accepted. It is not currently available for sale in the United States.
CaridianBCT is the leading global provider of innovative technologies and services specializing in automated blood collections, therapeutic apheresis and cell therapy systems, whole blood processes and pathogen reduction technologies. The company serves patients through its commitment "For Better Blood and Better Lives" by developing and commercializing products that serve global customers in the blood banking, therapeutic apheresis and transfusion medicine industries. For more information, visit www.caridianbct.com .
Lisa Hayes, Vice President of Global Marketing and Corporate Communications
Phone: +1 303.231.4201