Baxter International has announced US Food and Drug Administration (FDA) 510(k) clearance of the company’s ST Set, intended for use in continuous renal replacement therapy (CRRT). The ST Set is a pre-connected, disposable, extracorporeal circuit that provides blood purification through a semipermeable membrane to be used with Baxter’s PrisMax or Prismaflex control units (monitors).
It has been available in the USA since August 2020, when it received Emergency Use Authorisation from the FDA to provide CRRT to treat patients in an acute care environment during the COVID-19 pandemic, Baxter claims. The ST Set is currently in use across countries in Europe, the Asia-Pacific region, and North and South America.
“We are pleased to offer the ST Set to healthcare providers and hospitals in the USA on a permanent basis to continue helping them meet the diverse needs of patients treated with CRRT,” said Reaz Rasul, general manager of Baxter’s Acute Therapies business. “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].”
The ST Set includes three sizes (ST60, ST100 and ST150) that allow the healthcare provider to choose the most appropriate option for the patient, as per a Baxter press release. It features the company’s proprietary AN69 membrane, which can adsorb toxins with basic residues on the surface by means of ionic interactions. The ST Set works with all CRRT modalities and the majority of commonly used anticoagulants, the release adds.