Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system.
The company said this marks a step toward bringing a new standard of care in dialysis therapy to the U.S. Bad Homburg, Germany-based Fresenius can now begin U.S.-based clinical evaluations and user studies ahead of a broad launch in 2025.
Fresenius’ 5008X system offers industry-leading, high-volume hemodiafiltration dialysis therapy. Along with the companion FX CorAL dialyzer, it combines the latest device engineering and cutting-edge membrane technologies. The company says these technologies make high-volume hemodiafiltration possible.
This method of dialysis incorporates both diffusion and convection techniques. It eliminates larger molecules and effectively manages fluid replacement through convection.
Fresenius Medical Care says a study demonstrated that its system provided a 23% decrease in mortality rates compared to those treated with the more commonly used high-flux hemodialysis.
“Making new and innovative therapies available to patients is core to our goal of improving the lives of people living with kidney diseases,” said Helen Giza, CEO for Fresenius Medical Care AG. “The 5008X Hemodialysis System demonstrates our company’s ability to innovate at scale. This innovation builds on the proven track record of our hemodialysis system series in Europe, Latin America and Asia Pacific.” Helen Giza says: “We’re pleased to achieve this important milestone to bring a new standard of care in dialysis therapy to one of the world’s largest healthcare markets, where there is significant opportunity to make meaningful impact.”