Baxter (NYSE:BAX) announced today that it received FDA emergency use authorization (EUA) for its HF20 Set and ST Set for continuous renal replacement therapy (CRRT).
Under EUA, the HF20 Set can deliver CRRT to treat patients of low weight (8-20 kg) and low blood volume who can’t tolerate a larger extracorporeal circuit volume in an acute care environment during the COVID-19 pandemic. The ST Set now has authorization for providing CRRT for patients in acute care settings too, and both can be used with the Prismaflex or PrisMax control units, according to a news release.
Deerfield, Ill.-based Baxter’s HF20 Set offers low extracorporeal blood volumes (58 mL) and the PolyArylEtherSulfone (PAES) filter membrane, while the ST Set includes three sizes for patient-based variation and Baxter’s proprietary AN69 membrane for adsorbing toxins.
The company said a limited initial shipment of the HF20 Set and ST Set will be available in the U.S. “as soon as possible,” and will be followed by significant production increases down the line.
“With the continued need for CRRT products, the addition of the HF20 Set and ST Set offers healthcare providers and hospitals greater flexibility to meet the varying needs of patients, while making more CRRT sets available in the U.S.,” Baxter acute therapies GM Reaz Rasul said in the release. “With the HF20 Set, we are thrilled to help expand access to CRRT to low weight patients during the COVID-19 pandemic.”
The EUAs for the CRRT treatments follow the April authorization of Baxter’s Oxiris filter for use during blood during purification therapy to remove cytokines, endotoxin, fluid and uremic toxins simultaneously before returning the patient’s blood to their body.