Medtronic's CARPEDIEM Pediatric Dialysis System Receives FDA Approval for Use in Neonates as Light as 2.5 kg

Compiled by Fan Dongdong

On April 29 local time, the U.S. FDA announced that it had granted sales authorization for Medtronic’s CARPEDIEM device for hemodialysis or hemofiltration therapy, allowing the device to provide continuous hemodialysis or hemofiltration for critically ill pediatric patients weighing between 2.5 and 10 kg (or 5.5 and 22 pounds).

Continuous hemodialysis or hemofiltration, also known as Continuous Renal Replacement Therapy (CRRT), involves the use of a dialysis machine and specialized filters or dialyzers to continuously cleanse the patient’s blood over an extended period without interruption. This approach is considerably more convenient than conventional thrice-weekly treatments. CRRT is typically administered in the Intensive Care Unit (ICU). CARPEDIEM is the first CRRT device approved in the United States for pediatric patients with low body weight who experience acute kidney injury (AKI)—characterized by sudden or temporary loss of kidney function—or fluid overload due to impaired renal function. The CARPEDIEM system is a purification device designed for extracorporeal blood processing, whereby purified blood is returned to the patient’s body.

Dr. Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, stated: “When a child’s kidneys fail to function properly, continuous renal replacement therapy (CRRT) is required to remove harmful substances from the blood and alleviate a range of complications arising from kidney dysfunction. Pediatric patients requiring this therapy are typically critically ill and depend on dialysis for survival. Prior to the approval of the CARPEDIEM system, there were no CRRT devices available specifically for pediatric patients. The market launch of CARPEDIEM will advance kidney health care by becoming the first treatment option available in the United States for such patients, thereby addressing the clinical needs of critically ill patients who require ongoing renal replacement therapy to survive.”

In the United States, approximately 10,000 children experience acute kidney injury (AKI). These patients are typically treated in the intensive care unit (ICU), with a survival rate of only 38% to 43% among those requiring dialysis. However, existing continuous renal replacement therapy (CRRT) devices on the U.S. market are primarily designed for patients weighing more than 20 kilograms.

The approval of CARPEDIEM was primarily based on data from the European registry for CARPEDIEM, with results compared to patient data from the US prospective pediatric CRRT registry. The data showed that among patients weighing less than 10 kg treated with CARPEDIEM, the survival rate after discontinuation of CRRT reached 97%, whereas it was only 48% for those currently treated with adult CRRT devices. The survival rate at ICU discharge for patients treated with the CARPEDIEM system was 55%, compared to 43% for other CRRT devices. Furthermore, pediatric patients treated with the CARPEDIEM system experienced a significant reduction in fluid overload (FO) percentage. Studies have confirmed that FO is highly correlated with mortality in children receiving CRRT. Patients’ initial FO was 20%, which decreased to 5% following treatment with CARPEDIEM.

As part of the sales authorization, Medtronic will retain a post-approval study to document the real-world therapeutic use of the device in the United States. The study will collect data on patient survival rates following discontinuation of CRRT and after discharge from the ICU. Based on these clinical data, Medtronic may update the indications for use labeling to ensure broader, safer, and more effective utilization of the device.

Reference Source: FDA Grants Marketing of New Device for Continuous Dialysis Therapy for Use in Pediatric Patients with Certain Kidney Conditions