CytoSorb® is CE-mark approved in the E.U. in the U.S., CytoSorb® and DrugSorb-ATR® are investigational devices not yet FDA authorized/approved/cleared.
What we have seen, however, is that, by using the adsorber, we were able to reduce the hyperinflammation significantly and quickly to help the patient.
The reason for us to use CytoSorb in the ICU was the lack of treatment options. We never had anything in sepsis, and CytoSorb® is the new star on the horizon.
