FDA approves INTERCEPT Blood System for control of bleeding.- Cerus Corp

Cerus Corporation announced that the FDA has granted approval of the INTERCEPT Blood System for Cryoprecipitation. The system is used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. After thawing, Pathogen Reduced Cryoprecipitated Fibrinogen Complex remains transfusion-ready at room temperature for up to 5 days, continuously available for administration over this extended period. This product has been granted FDA Breakthrough Device designation based on the potential to improve treatment of massive hemorrhage, a life-threatening medical condition. In addition to use for treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex is also indicated for control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor are not available, for second-line therapy for von Willebrand disease, and for control of uremic bleeding after other treatment modalities have failed.