Access to the recently available HF20 filter—which provides continuous renal replacement therapy (CRRT) for small children—helped save the life of a bone marrow transplant recipient at Cincinnati Children’s.

Patient Paisley Palmer experienced veno occlusive disease (VOD), a side effect of previous chemotherapy treatment that blocks blood vessels on in the liver, causing fluid retention and swelling. The patient ended up in the pediatric intensive care unit. The Cincinnati Children’s nephrology team recognized this side effect early and was able to start addressing the patient’s condition with the HF20 filter to remove excess fluid from the body.

The Prismaflex HF20 filter is specifically designed to support critically ill children weighing between 8 and 20 kg who need CRRT. The HF20 low extracorporeal blood volume of 60 mL fills an on-label treatment niche not previously available in the United States.

This type of holistic, multidisciplinary innovative care is what makes Cincinnati Children’s stand out. It’s also an example of why Food and Drug Administration (FDA) approval is important to increase access to the HF20 filter, says Stuart Goldstein, MD, FAAP, director of the Center for Acute Care Nephrology. The nephrology center is most often the first to use new CRRT devices in children in the United States.

“We have the expertise for so many situations,” Goldstein says. “We were able to use the HF20 filter technology to save her life. She benefitted enormously from this filter designed to support someone of her size.”

Specialized Technology Enables Dialysis for Low Blood Volume Patients

The FDA issued an emergency use authorization for the HF20 filter to manufacturer Baxter International Inc. during the COVID-19 pandemic to make it accessible to children receiving intensive care for kidney injury or failure.

Goldstein hopes Paisley’s story above and others like it help the HF20 filter move closer to FDA approval; he has been working on this project for over a decade. Paisley’s mom Jessica Palmer says the universe aligned to put her family at Cincinnati Children’s. She’s beyond thankful that the HF20 filter technology was available.

“If this filter wasn’t available, it would have been so much harder on Paisley’s body. It was a gentler way to remove the fluid, and it helped her move toward recovery,” Jessica says. “I wholeheartedly believe that they put kids first at Cincinnati Children’s. And I am 150% certain we made the right decision to come here.”

Before the HF20 filter, physicians adapted adult technologies that use large extracorporeal volume. Goldstein and Cincinnati Children’s also led the way to FDA approval for Cardio-Renal Pediatric Dialysis Emergency Machine (CARPEDIEM) technology, which provides CRRT appropriately scaled for infants.

But CARPEDIEM cannot provide sufficient kidney support for children larger than 10 kg, Goldstein says.

Pushing for FDA Approval

Goldstein was the principal investigator of a multicenter study, which ran from 2016 to 2018 and proved the safety and efficacy of the new filter for small children. Cincinnati Children’s began using the HF20 filter set outside of the study in September 2020.

The FDA has since requested additional requirements for approval. Goldstein now leads a new HF20 filter set study, with Cincinnati Children’s as the central site. He’s partnered with Baxter to collect data “as expeditiously as possible so it can be approved for use after the emergency use authorization expires,” Goldstein says. “We want to make sure this doesn’t die on the vine.”

Goldstein says the HF20 filter set provides exceptional results and is being used by several hospitals around the country.

“We are able to support critically ill patients with the physicians and specialty expertise we have,” Goldstein says. “The HF20 dialysis filter is a specialized device for this important pediatric size range.”