May 4, 2020Regulatory
Acute kidney injury (AKI) is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in the blood and makes it hard for the kidneys to keep the right balance of fluid in the body. AKI can also affect other organs such as the brain, heart, and lungs. Acute kidney injury is common in patients who are in the hospital, in intensive care units, and especially in older adults.
Approximately 10,000 children develop AKI in the U.S. These children typically receive therapy in ICU settings and only have a survival rate of 38-43%. They need dialysis to survive. However, existing continuous renal replacement therapy (CRRT) devices available on the U.S. market are primarily intended for use in patients weighing at least 20 kilograms (or 44 pounds) and, therefore, are not approved for use in pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds) nor are they accurate enough to optimally treat these pediatric patients. 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 FDA has 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). 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).
The CARPEDIEM System was designed for extracorporeal blood treatment - a purification process that takes place outside the body returning the purified blood back to the patient. This was accomplished by optimizing technological features on legally marketed CRRT devices by miniaturizing the technology to meet the clinical needs of very small pediatric patients. The FDA evaluated data from an independent patient registry, the CARPEDIEM European Registry, and compared the results to control patient data from the United States Prospective Pediatric CRRT Registry. Data showed a 97% survival rate to discontinuation of CRRT in patients weighing less than 10 kilograms (or 22 pounds) treated with the CARPEDIEM System, compared to a 48% survival rate to discontinuation of CRRT in pediatric patients (controls) treated with currently cleared devices for CRRT marketed for adults. 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. In addition, pediatric patients treated with the CARPEDIEM System exhibited a significant decline in the percent of body fluid overload (FO), a measure that has been shown to be associated with higher mortality rates in children receiving CRRT. At the beginning of treatment, patients started with 20% of FO, but at the end their FO had decreased to 5%.
While the rates of complications reported from the CARPEDIEM European Registry were low, potential complications include weight scale alarm and low blood pressure. Potential complications associated with how the device functions include air in the dialysis circuit, transducer (assures that blood remains in the dialysis circuit) alarm and high pressure in the blood filter (dialyzer).
As part of the marketing authorization, the manufacturer will maintain a post-approval study to document real-world treatments of the device in the U.S. The study will gather data on patient survival rates after discontinuation of CRRT and timing of discharge from the ICU so the manufacturer can update labeling as needed to help ensure its safe and effective use by the wider pediatric nephrologist community.
The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
The FDA granted marketing authorization of the CARPEDIEM System to Medtronic Inc.