CytoSorbents Corporation (CTSO)

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Update on CytoSorb® therapy in liver dysfunction | Webinar Liver | 2022

Nov 1, 2022
Talk and Discussion: Maria Soledad Taborda Garcia, M.D

Moderation: Stefan Baudis

?? Disclaimer ??

Cytosorb®? is approved in the European Union with distribution in 65 countries around the world.
CytoSorb is indicated for use in conditions where elevated levels of cytokine and/or bilirubin and/or myoglobin exist. CytoSorb is indicated for use intraoperatively during cardio-pulmonary bypass surgery for removal of the P2Y12 inhibitor Ticagrelor and/or the Factor Xa inhibitor Rivaroxaban.

The statements here represent the personal opinions and views of the speaker only and do not necessarily reflect accepted medical knowledge in general or indications covered by the intended use of CytoSorb. CytoSorb must be used by health care professionals only.

On 10 April 2020 CytoSorb has also received FDA Emergency Use Authorization (EUA) in the United States for use in COVID-19 patients in the ICU with imminent or confirmed respiratory failure to reduce pro-inflammatory cytokine levels, 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 the FDA under an Emergency Use Authorization (EUA). The CytoSorb device is approved only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the CytoSorb device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

In Canada 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 Canadian authorities for importation and sale.

CytoSorb and CytoSorbents are trademarks of the CytoSorbents Corporation, USA.
©? Copyright 2022 CytoSorbents Europe GmbH. All rights reserve