The authorization is for the use of Oxiris in patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure that are in need of blood purification therapy to reduce pro-inflammatory cytokine levels. The EUA includes use in continuous renal replacement therapy (CRRT).
Deerfield, Ill.-based Baxter’s Oxiris filter is used during blood during purification therapy to remove cytokines, endotoxin, fluid and uremic toxins simultaneously before returning the patient’s blood to their body. Baxter touts Oxiris as the only filter in the U.S. that can perform these therapies simultaneously.
According to a Baxter news release, studies show that 15%-30% of patients with severe cases of COVID-19 are developing acute kidney injury (AKI), while 67% of severely ill COVID-19 patients may have additional organ dysfunction syndromes induced by cytokine storms.
Baxter intends to make a small shipment of Oxiris available in the U.S. immediately as it ramps up production in a significant manner over the next few weeks and months.
“We are doing whatever it takes to support healthcare providers as they care for patients during extraordinary circumstances,” Baxter chairman & CEO José Almeida said in the release. “Oxiris offers a new tool in the COVID-19 fight while supplementing our overall supply of filters for blood purification therapies. We are grateful for the FDA’s collaboration and support to make Oxiris available as quickly as possible to the influx of patients who are critically ill from COVID-19.”