Baxter (NYSE:BAX) announced today that it received FDA 510(k) clearance for its ST Set in continuous renal replacement therapy (CRRT).
Deerfield, Illinois-based Baxter designed the ST Set as a pre-connected, disposable, extracorporeal circuit that provides blood purification through a semipermeable membrane for use with the PrisMax or Prismaflex control units. The platform has been available to U.S. customers since August 2020 under FDA emergency use authorization (EUA) to provide CRRT in an acute care environment during the COVID-19 pandemic.
The ST Set includes three sizes to give healthcare providers appropriate options for varying patient needs. It includes Baxter’s proprietary AN69 membrane for adsorbing toxins with basic residues on the surface by means of ionic interactions.
According to a news release, Baxter’s ST Set works with all CRRT modalities and most commonly used anti-coagulants. It is currently in use across countries in Europe, Asia Pacific, North America and 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,” Baxter GM of Acute Therapies Reaz Rasul said in the release. “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).”