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CTSO : No Signal For Harm On CytoSorb Use In Patients Undergoing Surgery For Infective Endocarditis

CytoSorbents Corp. (CTSO), which provides the treatment of life-threatening conditions in intensive care and cardiac surgery using CytoSorb blood purification, made additional comments on the investigator-initiated REMOVE study following the formal presentation of trial results on October 16th at the EACTS annual meeting in Barcelona, Spain.

CytoSorbents sells a cytokine adsorbing column or "CytoSorb", a blood purification technology based on porous polymer beads that act like sponges in an attempt to remove harmful inflammatory mediators like Cytokines, Bilirubin, Myoglobin from the blood.

The presentation by REMOVE Study Director, med. Mahmoud Diab, from University Hospital Jena, Germany included additional patient demographic and adverse event data from the study. No study population subgroup analyses were reported.

Diab commented on safety and concluded that there was "no signal for harm due to the use of CytoSorb in patients undergoing surgery for infective endocarditis."

Professor Dr. med. Torsten Doenst, Head of the Cardiothoracic Surgery Department, University Hospital Jena, Germany, and coordinating center of the REMOVE study stated, The REMOVE results contribute significant and valuable information on the intraoperative use of CytoSorb in patients undergoing valve replacement surgery for infective endocarditis.

The pre-specified primary outcome of the study was neutral, but the company demonstrated CytoSorb's ability to reduce cytokines.

In addition, REMOVE also suggests that the use of CytoSorb in this setting is safe, with a similar adverse event profile to standard of care therapy.

Data suggest that the intraoperative use of CytoSorb in a general endocarditis patient population may not be helpful, but it is also not harmful, and it is conceivable that specific patient types may benefit from the therapy's ability to lower cytokine levels, Torsten Doenst said.

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