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⚠️ Disclaimer ⚠️
Statements made during the presentation are non-binding and cannot replace the therapy decisions of the treating physician, who is in all cases responsible for the development and implementation of an adequate diagnostic and therapeutic plan for each individual patient. The clinical and preclinical data and results obtained with the CytoSorb adsorber are not transferable to other products.
CytoSorb should only be administered by personnel who have been properly trained in administration of extracorporeal therapies.
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.
On 10 April 2020 CytoSorb has also 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.
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.
Негізгі бет Clinical effects - What are the most impressive clinical effects when you use CytoSorb?
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