Regulatory Status Overview CytoSorbents Products

CytoSorb 300:

CytoSorb® is approved in the European Union, with distribution authorized in more than 75 countries around the world.

 

CytoSorb is indicated for use in conditions where elevated levels of cytokines and/or bilirubin and/or myoglobin are present. CytoSorb is indicated for intraoperative use during cardiopulmonary bypass surgery for removal of the P2Y₁₂ inhibitor ticagrelor and/or the factor Xa inhibitor rivaroxaban.

 

CytoSorb is not yet approved or cleared in the United States or Canada for any indication outside an Emergency Use Authorization (EUA) by the US FDA.

 

The scope of the FDA EUA is limited to:

 

“The use of the CytoSorb device to treat patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure by reducing pro-inflammatory cytokine levels, which may ameliorate a cytokine storm due to the overabundance of pro-inflammatory cytokines and, in turn, provide clinical benefit to such patients. For the purposes of this EUA, a patient with confirmed COVID-19 who is admitted to the ICU with confirmed or imminent respiratory failure is a patient 18 years of age or older who has any one of the following conditions:

 

a) Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or

 

b) Severe disease, defined as:

1. dyspnea,
2. respiratory frequency ≥ 30/min,
3. blood oxygen saturation ≤ 93%,
4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
5. lung infiltrates > 50% within 24 to 48 hours; or

c) Life-threatening disease, defined as:

1. respiratory failure,
2. septic shock, and/or
3. multiple organ dysfunction or failure.”

ECOS 300-CY:

ECOS is approved in the European Union for removal of harmful substances from ex-vivo perfusion solutions as part of an ex-vivo perfusion system.

Intended Use: ECOS 300-CY (ECOS) is a non-pyrogenic, sterile, single-use polymer-based adsorption system designed for the dialysis of ex-vivo organ perfusion solutions in the field of extracorporeal therapies. ECOS is intended to be used with ex-vivo organ perfusion systems (e.g. ex-vivo normothermic/ hypothermic machine perfusion). ECOS is not yet approved or cleared in the United States or Canada for any indication.

 

PuriFi:

PuriFi is approved in the European Union for hemoadsorption treatments by use of a CytoSorb adsorption cartridge capable of retaining specific molecules responsible for development of particular diseases directly from the blood. PuriFi is not yet approved or cleared in the United States or Canada for any indication.

 

DrugSorb-ATR:

DrugSorb-ATR is an Investigational Device and not yet approved or cleared in the United States or Canada for any indication. DrugSorb-ATR is not yet approved or cleared in the European Union for any indication.

 

HemoDefend:

HemoDefend is not yet approved or cleared in the United States or Canada for any indication. HemoDefend is not yet approved or cleared in the European Union for any indication.