Fresenius Medical secures FDA approval for 5008X haemodialysis system

2024-02-09

Fresenius Medical’s 5008X Hemodialysis System, together with the FX CorAL dialyser, is designed to provide high-volume hemodiafiltration (Hv-HDF) dialysis therapy and combines the latest device engineering and membrane technologies Fresenius Medical Care brings advanced dialysis therapy to kidney disease patients in the US. (Credit: Fresenius Medical Care AG) Fresenius Medical Care, a provider of products and services for renal diseases, has received the US Food and Drug Administration (FDA) 510(k) approval for its 5008X Haemodialysis System. The 5008X Hemodialysis System is one of Fresenius Medical Care’s latest medical devices, designed to provide high-volume hemodiafiltration (Hv-HDF) dialysis therapy. Together with its companion FX CorAL dialyzer, the haemodialysis system combines the latest device engineering and membrane technologies to enable high-volume hemodiafiltration. With the FDA approval, the 5008X Hemodialysis System can be used in clinical evaluations and user studies in the US, with plans for a broad commercial launch in 2025. The 5008X Haemodialysis System and companion FX CorAL dialyser show the company’s global innovation leadership in medical device and membrane engineering technologies. Fresenius Medical Care CEO Helen Giza said: “Making new and innovative therapies available to patients is core to our goal of improving the lives of people living with kidney diseases. “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. “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 a significant opportunity to make a meaningful impact.” The results of the recently published CONVINCE study showed that treatment with high-volume hemodiafiltration resulted in 23% lower mortality rates compared to high-flux haemodialysis, said the company. The three-year, multinational research study, performed at 61 dialysis centres in eight European countries, compared the two types of haemodialysis techniques. Funded by the European Union (EU), the global randomised controlled study is conducted by the CONVINCE consortium and is led by the University Medical Centre Utrecht.

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