The EUA status enables Oxiris filter set to treat patients who have confirmed COVID-19 and admitted in the ICU with confirmed or imminent respiratory failure
Baxter has secured FDA EUA status for Oxiris blood purification filter to treat COVID-19 patients. (Credit: Baxter)
Baxter International has secured emergency use authorisation (EUA) from the US Food and Drug Administration for its Oxiris blood purification filter to treat COVID-19 patients.
The EUA status allows Oxiris filter set to treat patients who have confirmed COVID-19, as well as admitted in the intensive care unit (ICU) with confirmed or imminent respiratory failure and require blood purification therapy to minimise pro-inflammatory cytokine levels, including application in continuous renal replacement therapy (CRRT).
The patient’s blood runs through the Oxiris filter set during blood purification therapy. The Oxiris filter enables to remove cytokines, endotoxin, fluid and uremic toxins simultaneously, ahead returning the patient’s blood to the body.
Oxiris filter is suitable to conduct multiple blood purification therapies simultaneously
Oxiris is claimed to be the only filter set available in the US, which can be used to conduct multiple blood purification therapies simultaneously, including CRRT and cytokine removal.
Oxiris does not need the use of a second CRRT filter or adsorber compared to other products, enabling to conserve energy.
Oxiris, which is currently in use across countries in Europe and Asia, has been indicated for use with Baxter’s PrisMax and Prismaflex systems.
PrisMax has been introduced in the US last year, and it is firm’s next-generation blood purification platform that enables to simplify the delivery of the therapy.
Baxter said that it will begin a small initial shipment of Oxiris immediately and focuses on significantly increasing the production within short time.
Baxter International chairman and CEO said José (Joe) Almeida said: 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.
“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.”
In February, Baxter secured 510(k) clearance from the FDA for its new-generation Peri-Strips Dry with Veritas Collagen Matrix (PSDV) product, dubbed as PSDV with Secure Grip.