The U.S. FDA has granted emergency use authorizations (EUAs) to Baxter International Inc. for its HF20 Set and ST Set used in continuous renal replacement therapy (CRRT) during the COVID-19 pandemic. The two sets are intended for use with the company’s Prismaflex or Prismax CRRT monitors.
Acute kidney injury (AKI), where the kidneys suddenly can’t filter fluid and toxins from the blood, is a serious, potentially life-threatening complication of the novel coronavirus. According to a meta-analysis by researchers at Columbia University and New York-Presbyterian Hospital, of 13,000 hospitalized COVID-19 patients, 43% of whom were in intensive care or had severe infection, AKI prevalence averaged 17%.
CRRT replaces the normal blood-filtering function of the kidneys, providing continuous, round-the-clock therapy to support critically ill patients with AKI. Compared with standard dialysis, which takes about four hours, CRRT’s slower process puts less stress on the heart, though it requires special anticoagulation therapy to prevent clotting in the circuit.
COVID-19 increasing demand
“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.”
The FDA authorized the HF20 (hemofilter) set to deliver CRRT to patients of low weight (8-20 kg, or about 17 to 44 lbs.) and low blood volume who cannot tolerate a larger extracorporeal circuit volume in an acute care setting during the duration of the pandemic.
“Currently in the United States, low-weight patients requiring CRRT are generally treated with filter sets designed for higher-weight patients,” a Baxter spokesperson told BioWorld. “Enabling filter sets such as the HF20 set, that are designed for low-weight patients who have lower blood volume and are therefore susceptible to hemodynamic compromise with larger filter sets, can improve hemodynamic tolerance during therapy, mitigate the need for blood priming and prove effective and safe therapy to achieve the therapeutic goal in this patient population.”
The ST (surface treatment) set, which comes in three sizes, is authorized to provide CRRT to patients in an acute care environment during the COVID-19 pandemic. The surface treatment neutralizes the negatively charged based AN69 filter membrane for greater biocompatibility, a Baxter spokesperson said.
Both sets are authorized for use with all CRRT modalities, which includes slow continuous ultrafiltration, continuous veno-venous hemofiltration, continuous veno-venous hemodialysis and continuous veno-venous hemodiafiltration.
The company currently has ST sets in stock and is working to bring an initial shipment of the HF20 sets to the U.S. as quickly as possible, the spokesperson said. “In the meantime, inventory across our existing CRRT machines, sets and solutions is healthy in the U.S. We continue to meet the sustained increased demand we are seeing” as a result of the pandemic.”
Follows Oxiris EUA
The two sets mark Baxter’s latest EUAs for COVID-19 support. In April, the FDA authorized the company’s Oxiris filter set to reduce pro-inflammatory cytokine levels in the blood, including during CRRT, for ICU patients with confirmed COVID-19 and confirmed or imminent respiratory failure who are in need of blood purification.
The Oxiris filter set is being used at multiple facilities nationwide, the spokesperson said, noting demand has followed regional surges in infection.
All three products are CE-marked, but do not currently have FDA clearance.
“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,” the spokesperson said. “We are working with the FDA to determine the best pathway to obtaining permanent FDA approval of these products in the future.”
Other companies have stepped up to address the increased need for blood purification due to the pandemic. In April, Cytosorbents Inc. won EUA approval from the FDA for its Cytosorb extracorporeal blood purification cartridge for use in adults with confirmed COVID-19 infections. And in May, Health Canada approved an emergency interim order expanding the use of Toronto-based Spectral Medical Inc.’s Toraymyxin (PMX) hemoperfusion cartridge to include the treatment of COVID-19 patients with high levels of endotoxin in their blood and acute respiratory failure. The company is seeking FDA approval of the device.
Meanwhile, Outset Medical Inc. garnered FDA clearance this spring for its Tablo hemodialysis system for home dialysis use, reducing some of the demand for onsite devices that has spiked with COVID-19-driven dialysis treatments.