FDA grants marketing authorisation to First Pediatric acute Dialysis Machine

DUBLIN, - Medtronic plc (NYSE:MDT) today announced the U.S. commercial launch of the Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine. Following the U.S. Food and Drug Administration's (FDA) marketing authorization, granted earlier this year, the first Carpediem systems in the United States were successfully installed and are in use at Cincinnati Children's Hospital Medical Center. The first of its kind Carpediem™ system is indicated for use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.

Fluid overload is common in critically ill neonates and children, particularly after procedures such as cardiac surgery. The mortality rate for neonates with acute kidney injury has been reported to be as high as 60 percent.

"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," said Stuart L. Goldstein, M.D., professor of pediatrics and director, Center for Acute Care Nephrology at Cincinnati Children's Hospital Medical Center, who has been instrumental in raising awareness of the critical need for safe pediatric-specific dialysis. "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."