Sam Brusco, Associate Editor02.09.24
Fresenius Medical Care has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its 5008X hemodialysis system.
Instead of conventional high-flux hemodialysis that uses diffusion to eliminate small molecules from blood, 5008X’s high-volume hemodiafiltration uses both diffusion and convection to remove larger molecules as well. It also manages fluid replacement using convection.
The recently published, EU-funded CONVINCE study took place at 61 dialysis centers across eight European countries. Its data showed patients that underwent high-volume hemodiafiltration had 23% lower mortality rates than those treated with high-flux hemodialysis, at three years.
FMC plans to start U.S.-based clinical evaluations for 5008X and anticipates a broader maket launch in 2025.
"Making new and innovative therapies available to patients is core to our goal of improving the lives of people living with kidney diseases," said FMC AG’s CEO Helen Giza. "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."
She added: "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."
Instead of conventional high-flux hemodialysis that uses diffusion to eliminate small molecules from blood, 5008X’s high-volume hemodiafiltration uses both diffusion and convection to remove larger molecules as well. It also manages fluid replacement using convection.
The recently published, EU-funded CONVINCE study took place at 61 dialysis centers across eight European countries. Its data showed patients that underwent high-volume hemodiafiltration had 23% lower mortality rates than those treated with high-flux hemodialysis, at three years.
FMC plans to start U.S.-based clinical evaluations for 5008X and anticipates a broader maket launch in 2025.
"Making new and innovative therapies available to patients is core to our goal of improving the lives of people living with kidney diseases," said FMC AG’s CEO Helen Giza. "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."
She added: "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."