Institute of Good Manufacturing Practices India®

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Fresenius brings dialysis technology to the US with FDA approval

Fresenius Medical Care announced 510(k) clearance for its 5008X Hemodialysis System, a high-volume hemodiafiltration dialysis therapy device using diffusion and convection to eliminate waste in kidney disease patients' blood. Planning a broad market launch in the U.S. next year. 

Fresenius aims to establish hemodiafiltration as the new standard of care, prevalent in Europe since the 1970s. A decade-old trial demonstrated a 30% reduction in all-cause mortality with hemodiafiltration. Usage varies geographically, with over a quarter of Europe using it in 2017, while less than 1% did in North America, attributed to regulatory barriers and machine scarcity. 

FDA clearance for the 5008X addresses a barrier, supported by EU-funded study data. Despite statistical parity with hemodialysis in a recent trial, Fresenius envisions hemodiafiltration as the future standard, strategizing U.S. conversion. Clinical evaluations and studies precede a 2025 market launch. Regional experiences reveal suitability variations. In the U.K., it's restricted to patients with optimal vascular access and no limiting heart conditions.