FDA Gives Nod To Medtronic’s Hemodialysis Device For Pediatric Patients
The U.S. Food and Drug Administration granted marketing authorization to Medtronic Inc.’s CARPEDIEM System, a new device for continuous dialysis therapy for use in pediatric patients with certain kidney conditions.
The system is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms.
In the continuous hemodialysis or hemofiltration therapy, known as continuous renal replacement therapy or CRRT, a dialysis machine and a special filter, or dialyzer, will be used to continuously clean a patient’s blood for an extended period of time, without stopping. CRRT is typically performed in intensive care unit settings.
The CARPEDIEM System was designed for extracorporeal blood treatment, which is a purification process that takes place outside the body returning the purified blood back to the patient.
According to the agency, the CARPEDIEM System is the first CRRT device intended for a lower weight-specific pediatric patients with conditions such as acute kidney injury and fluid overload.
In the U.S., around 10,000 children develop acute kidney injury, and typically receive therapy in ICU settings with a survival rate of 38-43 percent. These children need dialysis to survive, but currently available CRRT devices on the U.S. market are primarily intended for use in patients weighing at least 20 kilograms.
The evaluation by FDA showed a 97 percent survival rate to discontinuation of CRRT in patients weighing less than 10 kilograms treated with the CARPEDIEM System, compared to a 48 percent survival rate to discontinuation of CRRT in pediatric patients treated with currently cleared devices for CRRT marketed for adults.
Further, the survival rate at discharge from the ICU was 55 percent in patients treated with the CARPEDIEM System, compared to 43 percent in patients treated with other CRRT devices.
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