The FDA granted a de novo clearance to a new device from Medtronic designed to continuously filter the blood of very small children and infants receiving intensive care for severe kidney injuries.
Picked up through its 2016 acquisition of Bellco, the Carpediem system provides continuous renal replacement therapy, known as CRRT, over an extended period of time compared to traditional dialysis sessions that run three times per week. It is designed for pediatric patients and neonates weighing between 5.5 and 22 pounds, or 2.5 to 10 kilograms.
It’s the first CRRT device intended for critically ill children this small, the FDA said, returning cleaned blood to those suffering from sudden loss of kidney function or who have too much water in their bodies.
“Patients who need this therapy are critically ill and require it to survive,” said Jeff Shuren, the agency’s device center director. “Before the CARPEDIEM System, there were no commercially available continuous renal replacement therapy devices for pediatric patients.”
Previous systems on the market were intended for people weighing at least 44 lbs, or 20 kgs, and have not been accurate enough for smaller patients. According to the FDA, about 10,000 children develop acute kidney injuries in the U.S. each year and have a survival rate between 38% and 43%.
Data from independent European and U.S. patient registries showed a 97% survival rate before the discontinuation of CRRT with the Carpediem system, compared to 48% in children treated with devices designed and marketed for adults. Among those discharged from the ICU, the survival rate reached 55% with the system versus 43% with others.
Shuren pointed to an initiative the Trump administration announced last summer focused on kidney disease and treatment development, saying, “this medical device will advance kidney health, providing a first of its kind option and meeting an unmet need for these critically ill patients who need continuous renal replacement therapy to survive.”