Baxter Granted EUAs by the FDA to Aid COVID-19 Patients
Among the many complications of a severe COVID-19 infection, as we have discovered, is acute kidney injury, or AKI. In this state, patients lose the ability to filter fluid and toxins from their blood, which if not addressed, could easily lead to loss of life. According to a joint study by Columbia University and the New York Presbyterian Hospital, AKI was found in 17% of patients who were either in intensive care or found to have severe infection.
Facing this challenge, Baxter has been granted emergency use authorizations (EUAs) by the FDA to help provide continuous renal replacement therapy (CRRT) through both its HF20 Set and ST Set. Although traditional therapy for kidney failure involves dialysis, CRRT represents a significant advancement of the procedure by providing less stress on the heart.
“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 Reaz Rasul, general manager of Baxter’s Acute Therapies business. “With the HF20 Set, we are thrilled to help expand access to CRRT to low-weight patients during the COVID-19 pandemic.”
This is not the first time Baxter has stepped in to provide additional support during the COVID-19 pandemic. In fact, since the pandemic began, Baxter has been granted four separate EUAs by the FDA. In April, for example, the FDA also authorized the company’s Oxiris filter set to reduce pro-inflammatory cytokine levels in the blood for ICU patients with COVID-19 in need of blood purification. Such a filter is particularly important for CRRT, which has been noted to increase filter clotting in patients due to cytokine storms that occur as a result of the virus.
“We decided to bring the HF20 set, ST set, and Oxiris to the U.S. via the EUA to help address the continued need for CRRT and extracorporeal blood purification products during the COVID-19 pandemic,” said a Baxter spokesperson. “We are working with the FDA to determine the best pathway to obtaining permanent FDA approval of these products in the future.”