First Dedicated Pediatric and Neonatal Acute Dialysis Machine Released U.S.

Medtronic is releasing in the United States the industry’s first and only dedicated pediatric and neonatal acute dialysis machine.

The Carpediem (Cardio-Renal Pediatric Dialysis Emergency Machine) has been in development for about a decade and the first in-human use was announced back in 2014. Having now received FDA marketing authorization, Medtronic is now making it available to hospitals around the country. Cincinnati Children’s Hospital Medical Center already has these installed and in use.

The continuous renal replacement therapy (CRRT) device is indicated for patients between 2.5 and 10 kilograms (5.5 to 22 pounds) with acute kidney injury, or that are fluid overloaded, and requiring hemodialysis or hemofiltration therapy.

Fluid overload is a common occurrence in children that undergo cardiac surgeries and acute kidney injuries can happen due to a variety of reasons. Typically, CRRT machines designed for adults are used off-label to treat neonates and young children, and the Carpediem device overcomes some of the limitations and risks associated with that approach.

“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, in a Medtronic press 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.”

Related: CA.R.PE.DI.E.M. (Cardio-Renal Pediatric Dialysis Emergency Machine): evolution of continuous renal replacement therapies in infants. A personal journey; Continuous renal replacement therapy in neonates and small infants: development and first-in-human use of a miniaturised machine (CARPEDIEM)

Via: Medtronic
Source link