The initiative supports FME’s ongoing rollout of high-volume HDF (HVHDF) across the United States and will help clinicians, patients and healthcare systems better understand how the therapy performs in routine clinical practice and across different patient populations, the company said in a news release.
According to Fresenius, HVHDF is an advanced dialysis therapy for people living with kidney failure. It combines diffusion, the principal mechanism used in conventional hemodialysis, with increased convection to remove a broader range of accumulated waste products from the blood.
“BEACON-US reflects our commitment to innovation that is grounded in evidence,” Helen Giza, CEO of Fresenius Medical Care, said in a news release. “High-volume hemodiafiltration has the potential to transform the standard of kidney care in the United States and is a key part of our FME Reignite strategy as we accelerate growth and innovation. We are excited by the benefits we are seeing through early insights from BEACON-US and the potential for this therapy to significantly improve patient outcomes.”
“The early U.S. experience with HVHDF is encouraging, with many patients feeling better during and after dialysis. For example, data show 40% fewer muscle cramps,” Charles Hugh-Jones, global chief medical officer at Fresenius Medical Care, said in a news release.
“More than 70% of treatments using AutoSub plus technology are already reaching the HVHDF target of at least 23 liters of convective volume per session and the emerging U.S. data align with the substantial body of international evidence, including the CONVINCE trial. Widely adopted as a standard of care in many countries around the world, HVHDF has been associated with fewer hospitalizations, better treatment tolerability, fewer episodes of low blood pressure during dialysis and improved survival outcomes. As the burden of kidney disease continues to grow, expanding access to therapies that may improve patient outcomes remains an important priority.”
U.S. data collection remains ongoing, with early observations showing that HVHDF is delivering strong clinical performance. The therapy has improved the achievement of dialysis adequacy targets (Kt/V) and enabled higher convective volumes without extending treatment times, while also reducing water consumption. Clinicians report that the technology’s intelligent automation simplifies workflows and helps optimize clinic resources, while creating a quieter treatment environment for both patients and staff.
According to Fresenius Medical Care, HVHDF is widely used internationally, and its evidence base includes randomized clinical trials and large observational studies from over 90 countries over the past two decades. Conducted in Europe and published in the New England Journal of Medicine, the CONVINCE trial reported a 23% lower risk of death from any cause among participants receiving HVHDF compared with those receiving conventional high-flux hemodialysis. The trial also reported improvements in patient-reported outcomes.
FME unveiled the Reignite strategy at its Capital Markets Day in London on June 17, 2025. “FME Reignite sets the ambition to deliver both industry-leading outcomes and margins1 with above-market growth,” Giza said in a news release.
FME earned FDA clearance for its 5008X hemodialysis system in early 2024. In 2025, it received FDA clearance for an updated version with added features. Implementation started in 2025, and the full commercial launch is currently underway, Giza said during the company’s 2026 annual meeting in May.
