FDA Grants Marketing of New Device for Continuous Dialysis Therapy for use in Pediatric Patients with Certain Kidney Conditions

The U.S. Food and Drug Administration  granted marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds). Continuous hemodialysis or hemofiltration therapy – known as continuous renal replacement therapy (CRRT) – involves using a dialysis machine and a special filter, or dialyzer, to continuously clean a patient’s blood for an extended period of time, without stopping, instead of the more traditional three times a week therapy session. CRRT is typically performed in intensive care unit (ICU) settings. The CARPEDIEM System is the first CRRT device intended for a lower weight-specific pediatric patient population (2.5 and 10 kilograms; or 5.5 to 22 pounds) who 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).

source https://www.pharmatutor.org/pharma-news/2020/fda-grants-marketing-of-new-device-for-continuous-dialysis-therapy-for-use-in-pediatric-patients-with-certain-kidney-conditions