Blood purification devices may be effective at treating certain patients with confirmed COVID-19 by reducing various pathogens, cytokines, and other inflammatory mediators, that is, small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that may occur in some COVID-19 patients, potentially leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.
The table below lists the authorization information for the use of specific blood purification devices during the COVID-19 public health emergency.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
|Date EUA Issued||Letter of Authorization||Assigned Product Code||Fact Sheets||Other Documents|
|04/09/2020||Terumo BCT Inc. and Marker Therapeutics AG Extracorporeal Blood Purification (EBP) Devices||QLO|
|04/10/2020||CytoSorbents, Inc. Extracorporeal Blood Purification (EBP) Device||QLO|
|04/17/2020||ExThera Medical Corporation Extracorporeal Blood Purification (EBP) Device||QLO|
|04/22/2020||Baxter Healthcare Corporation Extracorporeal Blood Purification (EBP) Device||QLO|