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. This updated system includes new capabilities, such as the Fresenius Clinical Data Exchange, which provides chairside access to medical information systems to improve workflow and reduce equipment clutter. The 5008X CAREsystem, combined with the FX CorAL dialyzer, is designed to deliver HVHDF therapy, a treatment already widely adopted in Europe, Asia, and Latin America. Helen Giza, CEO of Fresenius Medical Care, commented, “Last week’s FDA clearance of our updated 5008X CAREsystem with additional features was a critical milestone. We will set the new standard of kidney care in the U.S.”
The company 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's introduction is supported by the CONVINCE study, which reported a 23% reduction in mortality rates for patients undergoing HVHDF compared to traditional high-flux hemodialysis. Conducted across eight European countries, the study supports Fresenius' aim to expand access to advanced kidney replacement therapy across its clinic network and the broader U.S. dialysis market.
