Adding to yet other initiatives and accomplishments in the medical fraternity, a California-based pathogen-protected blood component developer and supplier company- Cerus Corporation has announced receiving an FDA approval for its INTERCEPT Blood System for CRYO.
As per various reports, the blood system is being used to form Pathogen-Reduced Cryoprecipitated Fibrinogen Complex to control and treat bleeding linked with fibrinogen deficiency.
It has been reported that Pathogen-Reduced Cryoprecipitated Fibrinogen Complex is generally used for regulating the bleeding when recombinant or/and specific virally inactivated preparation of von Willebrand factor or factor XIII are unavailable for 2nd line therapy for VWD (von Willebrand disease), and also for regulation of uremic bleeding post the failure of other treatment modalities. A main reason behind FDA approval of this product is its potential to enhance the treatment of massive hemorrhage.
Commenting on the recent accomplishment, William ‘Obi’ Greenman, the President and CEO of Cerus Corp. has cited that FDA nod for the system stands to be a vital step in the company’s mission of establishing pathogen reduction as standard for transfused blood components worldwide.
Moreover, the firm observes this novel move as a win for clinicians, hospitals, and patients while representing a new business model for the company. In addition to this, Cerus is also planning to commence distribution of this system across various parts of Texas, Wisconsin, California, and Louisiana by 2021.
Meanwhile, Dr. Philip C. Spinella, Director of CCRP (Critical Care Blood Research Program), and Prof. of Pediatrics at Washington University, commented that the university is optimistic that pathogen-reduced cryoprecipitated fibrinogen complex is potential of emerging as a valuable tool for therapies that are required to support damage control recovery for patients with life threatening bleeding.
It would be pivotal to mention that, in line with the FDA approval of Pathogen-Reduced Cryoprecipitated Fibrinogen Complex, a derivative production from its manufacturing- Cryoprecipitate Reduced- has also been accepted by the U.S. FDA for transfusion/therapeutic plasma exchange in patients with TTP.
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