Baxter Blood Purification Filter Secures US FDA Emergency Use Authorization for COVID-19 Treatment

(Deerfield, IL, USA) has received emergency use authorization (EUA) from the US FDA for the company’s Oxiris filter set to treat patients who have confirmed COVID-19 and have been admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy (CRRT).

In severe cases of COVID-19, patients may develop acute kidney injury (AKI), a condition where the kidneys suddenly stop working, and/or cytokine storms, which occur when high levels of the inflammatory mediators circulate in the blood as an intense immune reaction to the virus. Both conditions can be life-threatening and require intervention. Early studies suggest that 15 to 30% of patients with severe forms of COVID-19 are developing AKI, while 67% of severely ill patients with COVID-19 infection may present with additional organ dysfunction syndromes that could be induced by a high level of circulating cytokines.

During blood purification therapy, the patient’s blood passes through the Oxiris filter set, where it then removes cytokines, endotoxin, fluid and uremic toxins simultaneously, before returning the patient’s blood to the body. Oxiris is the only filter set available in the US that can be used to perform multiple blood purification therapies simultaneously, including CRRT and cytokine removal. When Oxiris is used, there is no change to traditional CRRT set up and delivery and no additional equipment is required for removal of inflammatory mediators. Unlike other products, Oxiris does not require the use of a second CRRT filter or adsorber, which can help conserve resources.

Oxiris is currently in use across countries in Europe and Asia, and has been validated for use with Baxter’s leading PrisMax and Prismaflex systems. Baxter is maximizing production of its CRRT machines, fluids and sets to help address unprecedented surges in demand for its acute dialysis products in Europe and the US.

“We are doing whatever it takes to support healthcare providers as they care for patients during extraordinary circumstances. Oxiris offers a new tool in the COVID-19 fight while supplementing our overall supply of filters for blood purification therapies,” said José (Joe) E. Almeida, chairman and chief executive officer. “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.”

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Baxter International Inc.