Fresenius Medical Care (FME) has commenced the US commercialisation of its high-volume haemodiafiltration (HVHDF) kidney replacement therapy, 5008X CAREsystem.
The full-scale commercial launch is anticipated by the company in 2026.
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FME secured the Food and Drug Administration’s (FDA) 510(k) clearance last week for the updated HDF-capable system.
In February 2024, FME first obtained the clearance for the 5008X CAREsystem, enabling focused testing and clinical assessments.
The latest clearance approves additional features, including the Fresenius Clinical Data Exchange (CDX), which facilitates ONE-TOUCH access to medical information systems, eliminating the need for extra computer stations.
The CDX claims to optimise clinic workflows, mitigate cross-contamination risks, and reduce citations under the CMS V-tag by streamlining data access and freeing up the clinic area by minimising the cabling clutter.
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By GlobalDataOver the coming months, FMS’ Care Delivery patient care business segment will start providing HDF dialysis therapy in chosen first wave clinics within its US Fresenius Kidney Care dialysis clinics network. This gradual rollout will continue throughout the year.
The 5008X CAREsystem, paired with the FDA-approved FX CorAL dialyser, represents a leap in medical device innovation by Fresenius. It not only enables HVHDF but also introduces enhancements in workflow and therapy.
The CONVINCE study, funded by the EU and conducted across eight European countries, found that subjects undergoing HVHDF had a significant 23% reduction in death rates against those receiving high-flux haemodialysis.
FME CEO Helen Giza said: “Last week’s FDA clearance of our updated 5008X CAREsystem with additional features was a critical milestone in our work to improve the lives of people living with kidney disease by bringing industry-leading, HVHDF dialysis therapy to the US.
“Haemodiafiltration is already the treatment standard across much of Europe, Latin America, and Asia, and we are very well experienced with it. Our great familiarity with this treatment, combined with the outcome and promising results of the external CONVINCE research study, reiterated the significant patient health and well-being benefits available with HVHDF.”
