Critically ill infants in need of continuous renal replacement therapy (CRRT) are often treated using machines intended for adults, leading to a number of challenges and a high risk of complications and death. Now, Medtronic plc has launched a pediatric and neonatal acute dialysis machine in the U.S. that is specifically designed for patients weighing between 2.5 and 10 kilograms.

The Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine, the first of its kind in the U.S., received U.S. FDA clearance in April via the de novo pathway and is classified as a class II device. The Dublin-based company plans a controlled national rollout focused on hospitals and neonatal and pediatric intensive care units with experience taking care of these patients.

“There’s a very careful selection process for this,” Ven Manda, president of renal care solutions at Medtronic, told BioWorld, noting that sites must be trained and certified by Medtronic before using the equipment. “Not every NICU or PICU in the country may actually get access to this in the first year.”

Small patient population, large unmet need

An estimated 10,000 children suffer from acute kidney injury (AKI) and require hospitalization in the U.S. each year. Of those, Medtronic believes up to 2,000 fit the patient profile and need indicated for Carpediem.

“It’s a relatively small patient population,” Manda acknowledged, “but … this goes straight to the mission, this is why we show up. When we realized there was unmet need here, we didn’t hesitate for more than a nanosecond to say, let’s get in, let’s see how we can address this unmet need.”

Critically ill patients are at high risk of fluid overload and AKI, in which the kidneys falter or fail to perform the vital role of filtering waste products and removing excess fluid from the blood to produce urine. In neonates and children, fluid overload is quite common following cardiac surgery for congenital heart disease.

“Unfortunately, acute kidney injury mortality in neonates, in particular, has been reported to be as high as 60%,” said Manda. “So it’s a very delicate and highly volatile patient population for which, up until now, there was not real reliable device.”

When placing babies and young children on CRRT, clinicians must ensure the amount of blood fed through the circuit is quite low – something adult dialysis machines are not designed for.

Specially designed for infants

“CRRT procedures performed for critically ill infants using previously available technology are not optimal because dialysis machines available in the U.S. are not designed to treat these small, fragile patients and can potentially expose them to many risks,” said Stuart Goldstein, professor of pediatrics and director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center, the first U.S. site to use the Carpediem system. “This new system is designed specifically for these patients, which enables increased precision of neonatal CRRT treatment and, potentially, reduces these risks.”

To perform CRRT safely on tiny patients, doctors must ensure that the blood that’s being pumped through the machine can be done at a lower rate that’s appropriate for their body size and weight. It is also crucial that the right amount of fluid is removed during treatment, as fluid buildup is bad for the heart and can increase mortality risks. Carpediem uses specialized scales and more fine-tuned and calibrated blood pumps that are specifically designed for patients under 10 kg.

Medtronic gained access to Carpediem through its 2016 acquisition of Italian med-tech company Bellco, and set about bringing the CE-marked system to the U.S. The company worked closely with the FDA to ascertain that there was no legally marketed predicate device in the U.S. market, clearing the way for a de novo classification and clearance of Carpediem.

To date, most of the experience with the system has come from Italy and other countries in Western Europe. Medtronic has recently begun to expand into other regions, including Latin America and parts of Africa, Manda said. Overall, “it’s been very well received.”

As it rolls out in the U.S., the hope is it will have a “giant impact” for the many NICUs and PICUs in the country that treat infant AKI patients.

“At Medtronic, we strive to provide a portfolio of renal care solutions that improves outcomes, access to care and quality of life for patients affected by severe renal injury or disease globally – no matter their size or age,” Manda said. “For the first time, some of the tiniest and most vulnerable patients can be treated with technology designed specifically for them.”