Medtronic launches first continuous dialysis machine for infants, small children in US
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Medtronic Inc. has announced the commercial launch of its pediatric emergency dialysis device, which is indicated for use in patients weighing between 5.5 and 22 pounds who experience AKI or fluid overload.
Healio Nephrology reported on the device, known as the Carpediem System, in April 2020 when Medtronic received marketing authorization from the FDA after data showed pediatric patients had a 97% survival rate when treated with the system vs. a 48% survival rate when treated with devices marketed for adults. As part of the authorization, Medtronic was required to conduct a post-approval study to monitor patients. According to a press release, the system was subsequently installed at Cincinnati Children’s Hospital Medical Center.
“[Continuous renal replacement therapy] CRRT procedures performed for critically ill infants using previously available technology are not optimal largely 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,” Stuart L. Goldstein, MD, professor of pediatrics and director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center, said in the release. “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.”
Ven Manda, president of Renal Care Solutions, part of the Medtronic Minimally Invasive Therapies Group, also commented on the device in the release.
“At Medtronic, we strive to provide a portfolio of renal care solutions that improve outcomes, access to care and quality of life for patients affected by severe renal injury or disease globally — no matter their size or age,” he said. “For the first time, some of the tiniest and most vulnerable patients can be treated with technology designed specifically for them.”
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