The FDA EUAs will allow Baxter to use HF20 Set and ST Set to better meet the increased demand for CRRT during Covid-19 pandemic
The US Food and Drug Administration (FDA) has granted emergency use authorisations (EUAs) for Baxter International’s HF20 Set and ST Set to deliver continuous renal replacement therapy (CRRT) during the Covid-19 pandemic.
The EUA status allows the HF20 Set to deliver CRRT for the treatment of patients of low weight between 8kg and 20kg, as well as low blood volume who are unable to tolerate a larger extracorporeal circuit volume in an acute care environment during the Covid-19 pandemic.
Baxter’s ST Set has received EUA status for ST Set to deliver CRRT for the treatment of patients in an acute care environment during the Covid-19 pandemic.
According to the company, CRRT enacts many of the functions of the natural kidney and is crucial for the treatment of patients with severe acute kidney injury (AKI).
The patient’s blood passes through a special filter during CRRT, where fluid and uremic toxins are eliminated before the cleaned blood is returned to the body.
Baxter’s HF20 Set provides low extracorporeal blood volumes (58mL) and the PolyArylEtherSulfone (PAES) filter membrane to free uremic toxins and manage fluid overload.
The ST Set is comprised of three sizes that help the healthcare provider to select the most suitable option for the patient. It is also provided with Baxter’s advanced AN69 membrane, which has the capacity to adsorb toxins with basic residues on the surface through ionic interactions.
Both the HF20 Set and ST Set are suitable for use with Baxter’s Prismaflex and PrisMax monitors
Both the HF20 Set and ST Set are pre-connected disposable sets suitable for use with Baxter’s Prismaflex and PrisMax monitors. They work with all CRRT modalities and the most commonly used anti-coagulants.
Baxter acute therapies business general manager Reaz Rasul said: “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 US.
“With the HF20 Set, we are thrilled to help expand access to CRRT to low weight patients during the Covid-19 pandemic.”
In April this year, Baxter secured FDA EUA status for its Oxiris blood purification filter to treat Covid-19 patients.