Baxter’s ST Set for Acute Kidney Injury Earns FDA Nod

Baxter has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its ST Set, a pre-connected, disposable, extracorporeal circuit used in continuous renal replacement therapy (CRRT).
 
The ST Set offers blood purification via a semipermeable membrane when used with Baxter’s PrisMax or Prismaflex control units. If features a proprietary AN69 membrane, which adsorbs toxins with basic residues on the surface via ionic interactions.
 
It’s been available in the U.S. since August 2020 when it was granted emergency use authorization (EUA) for CRRT in acute care during the COVID-19 pandemic. The ST Set is also used across Europe, Asia Pacific, and North/South America.
 
“We are pleased to offer the ST Set to healthcare providers and hospitals in the U.S. on a permanent basis to continue helping them meet the diverse needs of patients treated with CRRT,” Reaz Rasul, GM of Baxter’s Acute Therapies business told the press. “The ST Set has played an important role in increasing the availability of CRRT sets, which have been in high demand during the COVID-19 pandemic, and this clearance will help expand access to CRRT for patients with acute kidney injury (AKI).”
 
AKI, a sudden kidney function decrease over a period of hours, accumulates toxins and fluid in the blood that can lead to death if left untreated. CRRT mimics many natural kidney functions, passing patients’ blood through a filter like the ST Set to remove fluid and uremic toxins before returning the cleaned blood to the body.
 
The ST Set’s three sizes help clinicians choose the most appropriate option. It also works with all CRRT modalities and most commonly used anticoagulants, according to the company.