ST Set previously obtained FDA Emergency Use Authorization (EUA) to help meet increased demand for continuous renal replacement therapy (CRRT) products during the COVID-19 pandemic
Baxter International Inc. (NYSE:BAX), a global leader in acute care, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ST Set used in continuous renal replacement therapy (CRRT). The ST Set is a pre-connected, disposable, extracorporeal (outside the body) circuit that provides blood purification through a semipermeable membrane to be used with the PrisMax or Prismaflex control units (monitors). It has been available to customers in the U.S. since August 2020, when it received Emergency Use Authorization (EUA) from the FDA to provide CRRT to treat patients in an acute care environment during the COVID-19 pandemic. The ST Set is currently in use across countries in Europe, Asia Pacific and North 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,” 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).”
AKI is a sudden decrease in kidney function over a period of hours to days, often as a result of illness, trauma or infection. The sudden loss of kidney function leads to the accumulation of toxins and fluid in the blood that, if left untreated, may lead to death. AKI is an increasingly common complication of acute illnesses in intensive care units and hospitals1 2 3 and is one of many complications affecting COVID-19 patients. CRRT mimics many of the functions of the natural kidney and is the cornerstone of treatment in patients with severe AKI.4 During CRRT, the patient’s blood passes through a special filter, such as the ST Set, where fluid and uremic toxins are removed before the cleaned blood is returned to the body.
The ST Set includes three sizes (ST60, ST100 and ST150) that allow the healthcare provider to choose the most appropriate option for the patient. It features Baxter’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 most commonly used anti-coagulants.
Source: Company Press Release