Fresenius Medical Care has entered the next phase of its U.S. strategy to expand high-volume hemodiafiltration (HVHDF) therapy following FDA 510(k) clearance for the enhanced version of its 5008X CAREsystem. The updated system includes new capabilities designed to improve clinical workflows and represents a significant milestone in bringing advanced kidney replacement therapy to the U.S. market.
Enhanced System Features Drive Clinical Efficiency
The updated 5008X CAREsystem incorporates the Fresenius Clinical Data Exchange (CDX), a technology that provides chairside access to medical information systems. This feature enables one-touch access to providers' medical information systems directly at chairside without requiring additional computer stations, helping to optimize clinic workflows, reduce cross-contamination risks, and minimize equipment clutter.
The 5008X CAREsystem, combined with the FDA-approved FX CorAL dialyzer, is designed to deliver HVHDF therapy using cutting-edge membrane technologies and device engineering. The system represents one of Fresenius Medical Care's latest medical device innovations in kidney replacement therapy.
Clinical Evidence Supports Mortality Benefits
The introduction of HVHDF therapy is supported by results from the CONVINCE study, which demonstrated significant clinical benefits. The multinational research study showed that patients treated with high-volume hemodiafiltration experienced a 23% decrease in mortality rates compared to those treated with high-flux hemodialysis.
The CONVINCE study was a three-year randomized controlled trial conducted at 61 dialysis centers across eight European countries, funded by the European Union and led by the University Medical Center Utrecht. This groundbreaking research provides crucial evidence comparing the effectiveness of HVHDF with standard high-flux hemodialysis in the adult population.
Phased U.S. Market Introduction
Fresenius Medical Care will begin offering HVHDF in selected Fresenius Kidney Care clinics across the U.S. throughout 2025, with a full commercial launch planned for 2026. The therapy is already widely adopted as the treatment standard across much of Europe, Latin America, and Asia, where Fresenius Medical Care has extensive experience with the treatment modality.
"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," said Helen Giza, CEO of Fresenius Medical Care. "We will set the new standard of kidney care in the U.S."
Market Opportunity and Strategic Impact
The U.S. market presents significant opportunity for HVHDF adoption, with an estimated installed base of around 160,000 in-center hemodialysis machines across all service providers that could potentially be replaced to adapt this new standard of care. Introducing the 5008X CAREsystem and hemodiafiltration kidney replacement therapy represents a key pillar of Fresenius Medical Care's growth strategy.
The company first received 510(k) clearance for its 5008X CAREsystem in February 2024, which enabled focused testing, clinical evaluations, and user studies in a pilot clinic setting. The recent May 2025 FDA clearance for the updated system with additional features enables the broader commercialization efforts across the U.S. market.
