Cerus has received approval from the US Food and Drug Administration for its Intercept Blood System for plasma.
The approval has been granted for the system for ex vivo preparation of plasma, which will allow in reducing the risk of transfusion-transmitted infection (TTI) when treating patients requiring therapeutic plasma transfusion.
The system holds the capacity to inactivate a broad spectrum of enveloped viruses, non-enveloped viruses, Gram-positive and Gram-negative bacteria, spirochetes and parasites.
Cerus president and CEO William Obi Greenman said: "We believe this approval to be a pivotal step toward giving U.S. blood centers a proactive approach for protecting the plasma supply.
"Cerus’ 22 year commitment to improving transfusion safety has been essential to achieving the US approval for Intercept plasma, and our continued work with FDA on reaching an approval decision for the Intercept Blood System for platelets."
The Intercept Blood System includes single-use plasma processing sets and an ultraviolet (UVA) illumination device for the ex vivo preparation and storage of pathogen-reduced, whole blood-derived or apheresis plasma.
According to the company, the safety and efficacy of plasma prepared with the system has been evaluated in six clinical studies including a total of over 500 patients.