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Baxter Obtains 510(k) Clearance for ST Set
The Deerfield, IL-based company said the ST Set is used in continuous renal replacement therapy.
April 5, 2022
1 Min Read
Image courtesy of Kristoffer Tripplaar / Alamy Stock Photo
Baxter was awarded FDA clearance for a device it won Emergency Use Authorization for during the beginning of the pandemic. The Deerfield, IL-based company said it has received a nod from FDA for the ST Set used in continuous renal replacement therapy.
The company’s device 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).
“With the continued need for CRRT products, the addition of the HF20 Set and ST Set offers healthcare 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 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.
Baxter’s FDA clearance comes a few months after the company closed on acquiring Hillrom for $12.5 billion.
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