The power of care
Advancing kidney care: Introducing high-volume hemodiafiltration to the U.S.
In 2025, following Food and Drug Administration (FDA) clearance of the 5008X CAREsystem, Fresenius Medical Care (FME) began implementing high-volume hemodiafiltration (HVHDF) at our Fresenius Kidney Care center in Wellesley, Massachusetts, U.S. Paired with our FX CorAL dialyzer, the 5008X combines advanced engineering and membrane technologies to make HVHDF possible.
HVHDF is an in-center kidney replacement therapy that combines both convection and diffusion to remove solutes from the body. Unlike conventional hemodialysis, which primarily uses diffusion, HVHDF incorporates high-volume convective therapy, infusing additional fluid and removing larger middle molecules. FME has been successfully treating patients with HVHDF for over a decade in Europe, the Middle East, and Africa (EMEA). Having the ability to bring this therapy to the U.S. is an exciting opportunity to improve outcomes for patients on dialysis.
Innovation that patients can feel
This modality gained additional attention in 2023 with the release of the European Union-funded CONVINCE study comparing the efficacy of HVHDF with high-flux hemodialysis (HF-HD). After beginning the study in 2018, researchers observed more than 1,300 participants over two-and-a-half years. The results showed a 23% decrease in all-cause mortality on average for patients treated with HVHDF.
In 2024, results based on patient-reported outcomes from the CONVINCE study found that patients experienced an improved quality of life after treatment with HVHDF, such as increased cognitive and physical function. In 2025, we focused on translating these findings into clinical practice through the widespread adoption of HVHDF. Throughout this past year, we consolidated the evidence base by validating HVHDF’s cognitive benefits through real-world data collected across our European network. Additionally, through analyses of 2025 FME clinic data, we’ve confirmed sustained reductions in mortality and hospitalization rates. These latest results highlight the transition from clinical trial achievement to the establishment of HVHDF as a new standard of care in advanced dialysis treatment.
“We were very excited to be asked to be the pilot center for hemodiafiltration,” says Dr. Steven Spiegel, Medical Director of Fresenius Kidney Care, Wellesley. “We’re aware of the data showing improved outcomes, mortality benefits, and benefits in terms of how the patients feel. So, when we were asked, we were thrilled to do it.”
At Wellesley, patients are reporting that they feel stronger and more energetic. Care teams are also seeing improvements in labs and blood pressure before, during, and after treatment.
Nikolaos Koskinas, who goes by Niko, was our very first patient on HVHDF in the U.S. After switching from the standard in-center hemodialysis to HVHDF, Niko said he felt better; he had more energy, recovered faster after treatment, and could spend more time doing what he loves with the people who matter the most. Watch Niko’s story below.
“Being a part of a rollout like this makes me feel so proud… of myself and of my team here,” reflects Danielle Tressler, Clinic Manager of Fresenius Kidney Care, Wellesley. “It really gives us hope for the future that we will continue to advance technology in this way.”
The CONVINCE study was exclusively supported by the European Commission Research & Innovation, Horizon 2020, Call H2020-SC1-2016-2017 under the topic SC1-PM-10-2017: Comparing the effectiveness of existing healthcare interventions in the adult population (grant no 754803).
Publication date: March 2026
