Baxter Obtains 510(k) Clearance for ST Set

The Deerfield, IL-based company said the ST Set is used in continuous renal replacement therapy.

Omar Ford

April 5, 2022

1 Min Read
Baxter headquarters building
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.

 

 

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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