Device for Pediatric AKI Receives FDA HDE Approval

The US Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) Approval Order to the Selective Cytopheretic Device Pediatric, manufactured by SeaStar Medical Holding Corporation. The device is for use in children weighing 10 kg or more with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy. 

“This first regulatory approval is a major accomplishment for our company and, most importantly, it provides critically ill children with AKI access to a much-needed new therapy,” said Eric Schlorff, SeaStar Medical CEO. “We believe the HDE for children weighing as little as 10 kilograms—or roughly 22 pounds—acknowledges the proven lifesaving capabilities of our device and addresses a critical unmet need for patients.” 

The device is the first product from SeaStar’s Quelimmune product family. The FDA granted HDE approval to the Quelimmune pediatric device for AKI based on clinical results showing safety and probable clinical benefit to critically ill children with AKI who have few treatment options. Data from two noncontrolled studies supporting the device’s safety and probable benefits were recently published in the journal Kidney Medicine.

The FDA grants HDE approval to allow a medical device to be marketed without requiring the usual evidence of effectiveness. A device approved in this manner is called a humanitarian use device and is defined as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8000 individuals in the United States per year.”