FDA grants marketing authorization to device for continuous dialysis in pediatric patients
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The FDA has granted marketing authorization to Medtronic Inc. for a new device designed to provide continuous renal replacement therapy to pediatric patients with AKI or fluid overload, according to a press release from the agency.
According to the release, the Carpediem System is the first continuous renal replacement therapy (CRRT) device for use in patients who weigh between 5.5 pounds and 22 pounds, as most currently available devices for the therapy are intended for those who weigh at least 44 pounds.
According to the release, the technological features on CRRT devices already available in the United States were “miniaturized” to meet the needs of pediatric patients.
The FDA further noted data were first evaluated from the Carpediem European Registry and were then compared to results from the U.S. Prospective Pediatric CRRT Registry. These data demonstrated patients who weighed less than 22 pounds had a 97% survival rate when treated with the system compared to a 48% survival rate in pediatric patients treated with devices marketed for adults.
Complication rates for patients were low (mainly related to weight scale alarm and low blood pressure), while complications with the device itself included air in the dialysis circuit, transducer alarm and high pressure in the dialyzer, according to the release.
As part of the authorization, Medtronic Inc. will be required to conduct further research, or a post-approval study, to continue monitoring patient survival rates after discontinuation of CRRT and timing of discharge from the ICU.
“Before the Carpediem System, there were no commercially available continuous renal replacement therapy devices for pediatric patients,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “In line with the U.S. Department of Health and Human Services’ focus on improving the lives of Americans suffering from kidney disease and expanding options for these patients, 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.”
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