LAKEWOOD, Colo.--(BUSINESS WIRE)--Due to public health concerns over the transmission of chikungunya virus (CHIKV) and dengue fever, Terumo BCT will file a submission to the U.S. Food and Drug Administration (FDA) for expanded access use of the Mirasol® Pathogen Reduction Technology System for the treatment of platelets. The expanded access provision is meant to facilitate the availability of promising new therapies and diagnostic devices to patients as early in the development cycle as possible. The Mirasol system is generally used on platelets to reduce pathogens for which no comparable or satisfactory alternative exists.
The submission will include Banco de Sangre de Servicios Mutuos in Puerto Rico as an investigational site where the Mirasol system can treat platelets stored in plasma or platelet additive solution (PAS). The Mirasol system is a pathogen-reduction technology designed to render a broad range of disease-causing viruses, bacteria and parasites less pathogenic, and it inactivates residual white blood cells found in blood components.
KEY FACTS ABOUT THE MIRASOL SYSTEM:
- The Mirasol system has been designed to render a broad range of disease-causing viruses, bacteria and parasites less pathogenic, and to inactivate residual white blood cells found in blood components.
- The Mirasol system is the only device that uses riboflavin (vitamin B2) that is exposed to ultraviolet light to provide effective pathogen reduction and white blood cell inactivation.
- The Mirasol system is routinely used in numerous locations throughout Africa, Asia, Europe, Latin America and the Middle East.
- The Mirasol system is designed to deliver:
- An extra measure of safety in the face of emerging bloodborne infectious diseases
- Reduced risk from screened and unscreened pathogens as well as white blood cells
- An effective alternative to bacterial screening of platelets with no delay in product release
- Flexibility and ease of use for optimized operating efficiency
- Accurate reporting and traceability through fully integrated data capture
- While the Mirasol system is not yet approved for use in the United States, an Investigational Device Exemption would enable this program with Banco de Sangre de Servicios Mutuos to begin.
KEY QUOTES:
Ray Goodrich, PhD, Vice President of Scientific and Clinical Affairs, Terumo BCT
“With the FDA and Servicios Mutuos, we can improve the blood safety supply for patients using the Mirasol system. The system is intended to work by reducing the infectious levels of disease-causing agents in platelets and plasma while maintaining quality blood components. This treatment program enables us to promote blood safety with our technology.”
Gerardo Latoni, MD FCAP FASCP, Medical Director, Banco de Sangre de Servicios Mutuos
“The Mirasol system is routinely used in other parts of the world, giving an extra measure of safety against emerging bloodborne infectious agents including dengue fever and chikungunya virus (CHIKV). Our participation as an approved site for these therapies can help protect our patients from harmful pathogens.”
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 coupled with leading technologies in therapeutic apheresis and cell processing. 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.
