The Carpediem extracorporeal blood-filtration system was designed to provide continuous renal replacement therapy (CRRT) to critically ill patients weighing 5.5 to 22 lb. These patients must have a sudden or temporary loss of kidney function (acute kidney injury) or have too much water in their bodies because their kidneys are not functioning properly (fluid overload).
The device uses a special filter known as a dialyzer to continuously clean the blood for an extended period of time instead of the more traditional three times a week dialysis sessions. CRRT is typically performed in the intensive care unit (ICU).
Approximately 10,000 children develop acute kidney injury in the U.S., according to the FDA. These children typically receive therapy the ICU and have a survival rate of 38% t0 43%. Existing CRRT devices available on the U.S. market are primarily intended for use in patients weighing at least 44 lb.
The Carpediem European Registry showed a 97% survival rate to discontinuation of CRRT in patients weighing less than 22 lb treated with the system, compared to a 48% survival rate to discontinuation of CRRT in children treated with CRRT devices cleared for adults, according to the FDA. Complication rates were low, the agency noted.
The survival rate at discharge from the ICU was 55% in patients treated with the Carpediem system compared to 43% in patients treated with other CRRT devices. Patients who completed treatment with the Carpediem system exhibited 5% fluid overload, down from 20% at the beginning of treatment, the agency said.
Medtronic will conduct a post-approval study in the U.S. to gather data on patient survival rates after discontinuation of CRRT and timing of discharge from the ICU.
“Continuous renal replacement therapy is performed when a child’s kidneys are not working properly to remove bad substances from the blood and relieve some of the problems that result from the kidneys not working properly. Patients who need this therapy are critically ill and require it to survive,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release. “Before the Carpediem system, there were no commercially available continuous renal replacement therapy devices for pediatric patients.”