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Product safety

CytoSorb is CE approved, meets the biocompatibility requirements of ISO 10993, and is approved for cytokine and ticagrelor removal. To date, more than 88,000 individual applications have been performed in more than 800 clinical settings worldwide, and the application has proven to be well-tolerated and safe. The setup and application procedures are simple, safe and easy to perform after a short training session.

There is no need for equipment beyond the equipment routinely used in clinics for extracorporeal circulation (CRRT machines, HLM, ECMO). Anticoagulation can be done as usual with heparin or citrate and does not need to be adjusted because of the use of CytoSorb therapy.

CytoSorb is reliable, highly effective and safely reduces elevated levels of cytokines, bilirubin and/or myoglobin in the patient’s blood.

According to the current state of knowledge, there is no undesired elimination of physiological blood constituents, such as albumin and platelets, beyond that which can be expected within the scope of general hemofiltration or dialysis. (Ref: 1-8)

In addition, we have a number of case reports on the safe use of CytoSorb therapy in a variety of clinical indications. To the case series and case reports

References

(1) Einsatz eines Zytokinfilters in die Herz-Lungen-Maschine
Deppe AC, Weber C, Choi YH, Wahlers T.
Zeitschrift für Herz-,Thorax- und Gefäßchirurgie 30(4): 254-259

(2) Effect of hemoadsorption during cardiopulmonary bypass surgery – a blinded, randomized, controlled pilot study using a novel adsorbent.
Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preissing F, Wiedemann D, Hiesmayr MJ, Spittler A.
Crit Care 2016 20(1): 96

(3) Treatment of post-cardiopulmonary bypass SIRS by hemoadsorption: a case series
Trager K, Fritzler D, Fischer G, Schroder J, Skrabal C, Liebold A, Reinelt H
Int J Artif Organs 2016; 39(3): 141-146

(4) A multicenter randomized controlled study of an extracorporeal cytokine hemoadsorption device in septic patients
Schädler D, Porzelius C, Jörres A, Marx G, Meier-Hellmann A, Putensen C, Quintel M, Spies C, Engel C, Weiler N, Kuhlmann M
Critical Care 2013, 17(Suppl 2):P62

(5) Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study
Hawchar F, László I, Öveges N, Trásy D, Ondrik Z, Molnar Z
Journal of Critical Care 2019; 49:172-178

(6) Extracorporeal Cytokine Elimination as Rescue Therapy in Refractory Septic Shock – a Prospective Single-Center Study
Friesecke S, Stecher SS, Gross S, Felix SB, Nierhaus A
Journal Artif Organs 2017; 20(3): 252-9

(7) Cytokine clearance with CytoSorb during cardiac surgery: A pilot randomized controlled trial
Poli EC, Alberio L, Bauer-Doerries A, Marcucci C, Roumy A, Kirsch M, De Stefano E, Liaudet L, Schneider AG
Critical Care 2019; 108

(8) Feasibility and safety of combined cytokine adsorption and continuous veno-venous hemodialysis with regional citrate anticoagulation in patients with septic shock
Dimski T, Brandenburger T, Slowinski T, Kindgen-Milles D.
Int J Artif Organs 2019; epub