CytoSorbents Corporation
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 152,000 human treatments to date. CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Clinical Services
- Market Focus:
- Globally (various continents)
About Us
Initial reports suggest that COVID-19 is associated with severe disease that requires intensive care in approximately 5% of proven infections. The virus can result in a dysregulated immune response and this cytokine storm seems to be associated with disease severity, as it can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ARDS).
In addition to ARDS, further complications in the critically ill include shock, acute cardiac injury and AKI. This is in line with what is known from other viral infections such as influenza and previous coronavirus infections (SARS, MERS), as well as with the general fact that infectious and non-infectious triggers can result in a cytokine storm, progressing to vasoplegic shock and finally multi-organ dysfunction syndrome.
In the USA:
- The CytoSorb device has neither been cleared or approved for the indication to treat patients with COVID-19 infection.
- The CytoSorb device has been authorized by FDA under an Emergency Use Authorization (EUA).
- The CytoSorb device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the CytoSorb device undersection 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
CytoSorbents worldwide
CytoSorbents products are currently distributed in more than 58 countries around the world on four continents. On this page you will find the distributor for your country. If the contact you are looking for is not available, please contact us: support(at)cytosorbents.com
Rationale of using CytoSorb Therapy in critically ill COVID-19 patients
CytoSorb is a CE marked extracorporeal cytokine adsorber, designed to broadly reduce inflammatory mediators in the blood that could otherwise lead to uncontrolled systemic inflammation, organ failure, and death in many life-threatening illnesses. CytoSorb has been used safely in more than 152,000 treatments worldwide, primarily in the treatment of systemic hyperinflammation in a wide variety of life-threatening conditions.
On 10 April 2020 the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) (*) for emergency use of CytoSorb 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.
Experience in treating patients with COVID-19 infection
The rationale of using blood purification to treat the cytokine storm in critically-ill COVID-19 patients was recently detailed in a recent publication that concluded, “Finally, a sepsis-like syndrome might occur frequently due to the virus itself or to a superimposed bacterial infection and in this case, since pharmacological approaches have shown poor results, new extracorporeal organ support therapies including hemoadsorption and hemoperfusion, with new sorbent cartridges designed to remove cytokines and other circulating mediators, should be considered.” (1)
To date, more than 5,750 critically ill patients with COVID-19 infection have been treated with CytoSorb in 30 countries.