Pathogen reduction technology to be used in combating bloodborne infectious diseases
LAKEWOOD, Colo - Wednesday, November 19th 2014 [ME NewsWire]
(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.
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Contacts
Terumo BCT
D.J. Martin,
+1-303-239-2060
Global Corporate Communications
press@terumobct.com
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