By Andrea Park 

In comparison to the flood of emergency use authorizations doled out by the FDA throughout the COVID-19 pandemic, the number of those tests and devices that have gone on to receive full, non-pandemic clearance from the agency looks more like a trickle.

Among the lucky few given the green light to stick around—as announced this week—is a dialysis system from Baxter International that first locked down an EUA in August 2020.

The ST Set offers continuous renal replacement therapy, or CRRT, a form of dialysis that filters the blood more slowly than standard hemodialysis machines. The gentler, around-the-clock therapy is typically reserved for patients hospitalized with acute kidney injury who wouldn’t be able to handle the stress of three-hour sessions of regular dialysis.

With the expanded FDA clearance, the circuit system will now be available to hospitals and healthcare providers throughout the US on a permanent basis, according to general manager of Baxter’s acute therapies business, Reaz Rasul.

“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,” Rasul said.

The disposable ST Set mimics many functions of the kidney for patients experiencing severe cases of acute kidney injury, in which a decrease in the organ’s function—caused by illness, injury or infection—causes a potentially fatal buildup of toxins and fluids in the bloodstream.

The system remains outside the body, where blood is filtered out and through Baxter’s AN69 semipermeable membrane. As the blood passes through the filter, the toxins’ ions interact with the membrane, catching the extraneous material on the surface of the filter.

The ST Set is meant to be connected to Baxter’s PrisMax or Prismaflex control units, both of which are cart-based systems equipped with monitors to provide real-time monitoring for CRRT and other therapies in the ICU.

The system was initially granted the FDA’s emergency OK within the first few months of the COVID pandemic. At the time, studies showed that of patients who had to be hospitalized with the coronavirus, around one in five developed acute kidney injury as a complication of the virus.

Alongside the ST Set’s EUA, Baxter received another emergency nod for its HF20 Set, which is specifically designed for patients of low weight and blood volume who require a shorter circuit system for their continuous renal replacement therapy.