Study represents a new milestone toward increasing transfusion safety
LAKEWOOD, Colo.—April 19, 2012—Terumo BCT has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to conduct studies for packed red blood cells derived from whole blood treated by the Mirasol System for Whole Blood. IDE approval allows Terumo BCT to begin preparations for feasibility testing of red blood cell recovery and survival derived from Mirasol-treated whole blood and stored under standard conditions. The Mirasol system uses a combination of riboflavin (vitamin B2), a non-toxic, naturally occurring compound, and a specific spectrum of ultraviolet (UV) light to inactivate viruses, bacteria, parasites and white blood cells that may be present in collected blood products.
The objective and design of the study will:
Evaluate the in vivo behavior of red blood cells in healthy human subjects after treatment with the Mirasol system.
Ensure that the Mirasol system maintains adequate performance of the treated red blood cells and to evaluate the safety of the system.
Supports future filings for regulatory approvals in the United States.
The study will begin this year, studying individuals—regular blood donors—who volunteer to participate in the interest of ultimately increasing transfusion safety.
Selected sites in the United States will conduct the controlled, randomized, cross-over study.
First participant enrollment is expected to begin this year, with the entire study taking six to 12 months to complete. Up to 30 evaluable, consenting subjects will participate in two arms of the study: once donating one unit of fresh whole blood that is then Mirasol-treated, and once donating a unit that is not Mirasol-treated.
The Terumo BCT organization was awarded a U.S. Department of Defense (DoD) grant in 2009 from the Congressionally Directed Medical Research Programs (CDMRP) for pre-clinical work to develop a pathogen reduction technology for whole blood that can reduce the risk of infectious disease transmission and unwanted transfusion reactions. This pre-clinical development work provided the data supporting the IDE application.
Kris Stegner, Ph.D., M.B.A., Director, Global Clinical Affairs, Terumo BCT
"This approval is a testament to the extensive and robust evidence we have generated through our development efforts, and we are grateful for the U.S. Department of Defense and its support of these initiatives."
"The data from our current studies provide strong backing for the Mirasol technology and the effective inactivation of bloodborne pathogens and donor leukocytes to reduce complications from red blood cell transfusions. Now the feasibility study will help us take that body of evidence to the next level, as it represents the first step toward eventually introducing pathogen reduction in the United States."
Note: The Mirasol system is not FDA-approved for sale in the United States.
About Terumo BCT:
Terumo BCT, a global leader in blood component 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.
About Terumo Corporation:
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
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