FDA grants emergency use authorization to Baxter for dialysis sets in COVID-19 pandemic
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Baxter International Inc. has obtained two emergency use authorizations from the FDA for patients who may develop AKI during the COVID-19 pandemic.
Both emergency use authorization-designated products, entitled the HF20 Set and ST Set, are intended for patients requiring continuous renal replacement therapy (CRRT), according to a company press release.
The release elaborated on the products, explaining that the HF20 Set is now authorized to deliver CRRT to patients weighing 8 kg to 20 kg (described here as “low weight”) and with low blood volume. According to the release, these patients “cannot tolerate a larger extracorporeal circuit volume in an acute care environment.”
Of the emergency use authorization for the HF20 Set, Reaz Rasul, general manager of acute therapies business for Baxter, said, “We are thrilled to help expand access to CRRT to low- weight patients during the COVID-19 pandemic.”
The ST Set is now also authorized for use under its emergency use authorization to provide CRRT to treat patients in an acute care environment, with the release noting that both sets can be used with Baxter’s Prismaflex and PrisMax monitors. Further, according to the release, the products work will all CRRT modalities and can also be used with most anti-coagulants.
The release added that while the HF20 Set and ST Set have not yet been cleared or approved by the FDA, the products have been used for more than a decade in Europe.
“With the continued need for CRRT products, the addition of the HF20 Set and ST Set offers health care providers and hospitals greater flexibility to meet the varying needs of patients, while making more CRRT sets available in the U.S.,” said.
For more information, including safety considerations for both products, visit: https://www.baxter.com/baxter-newsroom/baxter-obtains-us-fda-emergency-use-authorizations-hf20-set-and-st-set-used-crrt.
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