Mirasol-treated Fresh Frozen Plasma (FFP) meets Council of Europe guidelines (14th Edition) for protein content of FFP
CaridianBCT, formerly Gambro BCT, announced today that its wholly owned subsidiary, CaridianBCT Biotechnologies, received a CE Mark for the Mirasol Pathogen Reduction Technology (PRT) System for Plasma for transfusion. This expands the initial CE Mark approval of the Mirasol PRT System for Platelets granted in October 2007. The company can now begin marketing and selling the Mirasol PRT system to reduce the active pathogen load and neutralize white blood cells in donor plasma for transfusion in various geographies in Europe, Africa, and the Middle East.
Fresh Frozen Plasma (FFP) is produced from approximately 20-30% of collected whole blood units and used in a variety of key medical treatments. Historically transmission of pathogens has been associated with the transfusion of FFP and a number of techniques have been experimented with over the years as preventative measures.
The Mirasol PRT system is a groundbreaking new technology based on ultraviolet (UV) light and riboflavin (vitamin B2) that has the potential to inactivate pathogens in all three major blood components: platelets, plasma, and red blood cells. A unique feature of Mirasol is its use of riboflavin, a compound that has been shown to be non-toxic and non-mutagenic. The residual riboflavin and any photoproducts produced during the process do not present any hazardous risks to the blood handler or patient, eliminating the need to remove it prior to transfusion.
“Our system is setting a new standard for improving the safety of the blood supply without compromising quality and performance,” said Senior Vice President and General Manager, Pathogen Reduction Technologies, Teresa Ayers. “Based on safe, simple, and efficient methods using naturally-occurring riboflavin (vitamin B2) and UV light, the Mirasol PRT system fits easily into our customers’ workflow allowing for rapid release of platelets and plasma after illumination.”
The Mirasol PRT system has been under extensive scientific research, development, and testing since 1999 and has been evaluated for its effectiveness against a broad range of disease-causing agents including viruses, bacteria, parasites and white blood cells. Most recently, the safety and efficacy of the system has been established in a multi-center clinical evaluation in thrombocytopenic patients, which resulted in the CE Mark approval of the Mirasol System for Platelets.
“Receiving the CE Mark on the Mirasol PRT System for Plasma for transfusion is a significant milestone for CaridianBCT and will provide our customers with a state-of-the-art treatment option to improve blood safety by reducing the pathogens found in collected blood,” said President and Chief Executive Officer David B. Perez. “We are committed to serving our customers and the patients who are the ultimate beneficiaries of the life saving gift of blood, by developing new innovations to increase the safety of the blood supply.”
The CE Mark is a mandatory European marking for medical devices indicating that the product has been shown to meet the essential health and safety requirements of the European Medical Device Directive. The Mirasol PRT system is not available for sale in the United States at this time.
CaridianBCT, Inc. improves lives through innovation, quality and services delivered by its people, products and processes in blood component technology. It is a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies—serving blood banks, hospitals and clinical and biotech research facilities. Headquartered in Lakewood, CO., the company has global operations in 32 countries and employs more than 2400 people.
Lisa Hayes, Vice President of Global Marketing and Corporate Communications
Phone: +1 303.231.4201