Carpediem by Medtronic, the only pediatric and neonatal acute dialysis machine in the USA got the FDA authorization earlier this year. It now gets installed at Cincinnati Children’s Hospital Medical Center.
Approximately, 18.5-58.3 per million children suffer from kidney disease worldwide. About 70% of them develop kidney failure by age 20 years. Affected children typically receive therapy in the intensive care unit (ICU) with a survival rate of 38-43%. Dialysis can improve their survival. The continuous renal replacement therapy (CRRT) devices available in the U.S. are mostly suitable for adults. In other words, for individuals weighing at least 20 kilograms (or 44 pounds). Here is where Carpediem helps!
Carpediem fills the gap in the renal management of the pediatric population. It is the first CRRT system for pediatric patients. Carpediem successfully provides CRRT to children weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds).
Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health said:
“Continuous renal replacement therapy is performed when a child’s kidneys are not working properly to remove bad substances from the blood and relieve some of the problems that result from the kidneys not working properly. Patients who need this therapy are critically ill and require it to survive. Before the CARPEDIEM System, there were no commercially available continuous renal replacement therapy devices for pediatric patients. 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.“
Professor Stuart Goldstein at Cincinnati Children’s Hospital Medical Centre pediatrics said:
“CRRT procedures performed for critically ill infants using previously available technology are not optimal largely. This is because dialysis machines available in the U.S. are not suitable to treat these small, fragile patients, and can potentially expose them to many risks. This new system is designed specifically for these patients which enables increased precision of neonatal CRRT treatment and, potentially, reduces these risks. We are grateful to be the first site in the U.S. with this technology to help the children in our care.”
The success rate of Carpediem:
Studies have shown an increase in the survival rate to discontinuation of CRRT of patients weighing less than 10 kgs from 48% to 97%. In other words, with the CRRT devices for adults, the survival rate for children was only 48%. With Carpedeim, survival has been markedly raised. Additionally, the survival rate at discharge from the ICU has increased to 55% from the previous 43%.
Overall, the complication rate is low. But there are some potential risks, including weight scale alarm and low blood pressure. The device-related complications include air in the dialysis circuit, transducer (assures that blood remains in the dialysis circuit) alarm, and high pressure in the blood filter (dialyzer).
“For the first time, some of the tiniest and most vulnerable patients can be treated with technology designed specifically for them. We cannot make the world a healthier place alone. That is why collaboration with clinical experts, such as Prof. Ronco and Dr. Goldstein, is critical to bringing new treatment options to underserved populations.”