Medtronic received De Novo authorization from FDA for a device designed to provide continuous dialysis therapy to critically ill small children, the agency disclosed Wednesday.
The authorization will enable physicians to offer continuous renal replacement therapy (CRRT) to small pediatric patients without resorting to the off-label use of devices designed for larger children and adults.
Medtronic plans to make the system, branded Carpediem, available through a “controlled market release” over the coming six months, a company spokesperson told MedTech Dive.
Physicians face challenges when treating infants and other young children with acute kidney injury. CRRT can support patients by continuously cleaning their blood. However, CRRT devices available in the U.S. are designed for use in people who weigh upwards of 20 kilograms, or about 44 pounds, a weight that children typically pass by the age of six.
Devices designed for people who weigh 20 kilograms or more have been used in smaller pediatric patients, but doing so creates problems. As young children have smaller volumes of blood, the effect of errors is amplified, putting patient safety at risk. Also, the alarms of existing devices are calibrated for bigger people.
Bellco, an Italian medtech company, worked with researchers in its home country to create a device tailored to the needs of these smaller patients. In 2016, Medtronic bought Bellco and set about bringing the CE-marked medical device to the U.S. market.
That effort paid off this week when FDA granted De Novo authorization to Carpediem. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, outlined the significance, in a statement noting that “before the Carpediem System, there were no commercially available continuous renal replacement therapy devices for pediatric patients.”
FDA said it assessed the device using data from a European registry, comparing results to control patients tracked in the U.S. Prospective Pediatric CRRT Registry. Medtronic will be required to maintain a post-approval study of the device to track patient survival post-CRRT and timing of discharge from the ICU.
Medtronic plans to make the product available gradually in the first six months of its 2021 financial year, which recently got underway. The company already sells the CE-marked device in parts of Europe, the Middle East, Asia Pacific and the Americas.
The authorization gives Medtronic a chance to dominate a niche. Baxter trialed its CRRT system in infants weighing 8 kilograms to 20 kilograms but terminated the study in 2018. Medtronic’s clearance covers the use of Carpediem in children weighing 2.5 kilograms to 10 kilograms — a population traditionally underserved by the medical device industry. Only a few devices a year, at best, are authorized in neonates and infants aged two years and younger.
Medtronic’s receipt of a rare authorization for a device available to newborns makes it one of just a handful of companies to be granted a De Novo so far this year. Over the first four months of 2019, FDA cleared 11 devices for use under the pathway, according to the agency's database. So far in 2020, FDA has added five devices to the database, not including Carpediem.