FDA OKs Device for Pediatric Kidney Injury Due to Sepsis

The FDA gave the green light to a new device for treating children with acute kidney injury (AKI) due to sepsis or a septic condition who require kidney replacement therapy (KRT), SeaStar Medical announced Thursday.

Granted a Humanitarian Device Exemption (HDE) approval order, the selective cytopheretic device can be used in kids weighing 10 kg or more. This is the first product in the company’s Quelimmune product family.

The HDE is different from other approval pathways in that HDE-approved devices aren’t required to demonstrate “a reasonable assurance of effectiveness, and instead requires demonstration of probable benefit” after taking into account other currently available devices or treatments, the FDA explained.

“We believe the HDE for children weighing as little as 10 kilograms — or roughly 22 pounds — acknowledges the proven life-saving capabilities of our device and addresses a critical unmet need for patients,” said Eric Schlorff, CEO of SeaStar Medical, in the press release. “We are working to make Quelimmune therapy the new standard of care for AKI requiring continuous renal replacement therapy in the ICU and to demonstrate its benefit in the many indications where hyperinflammation and dysregulated inflammatory processes are involved.”

Pooled data from two small FDA-funded studies supported the HDE approval, showing “probable clinical benefit to critically ill children with AKI who have few treatment options,” SeaStar said.

The studies included a total of 22 pediatric patients. The first study, which included kids who weighed 33 lb or more, reported a 75% reduction in mortality. In the second study involving kids weighing 22 lb and more, there was an 83% mortality reduction. By day 60 of device use, pediatric patients had no device-related serious adverse events or device-related infections, no dialysis dependency, and there was a 77% reduction in mortality.

The cell-directed extracorporeal device works by using immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy and reduces the hyperinflammatory milieu, including the cytokine storm that causes inflammation, organ failure, and possible death in critically ill patients.

It’s different than other pathogen removal and other blood-purification tools because it is integrated with the continuous renal replacement therapy hemofiltration systems in order to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. The therapy is designed to selectively target the most highly activated proinflammatory neutrophils and monocytes, which are then returned back into the blood where the body is signaled to decrease its inflammatory environment and focus on repairing itself.

“This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis,” the company’s statement noted.

SeaStar is currently testing the device in critically ill adults with AKI and looking at other applications.

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