Dear Physician Colleagues,

We are proud to mark a pivotal moment in the evolution of kidney replacement therapy: the emergence of high-volume hemodiafiltration (HVHDF) as a new standard of care for patients with end-stage kidney disease (ESKD).

At Fresenius Medical Care, we have long believed in the transformative potential of HVHDF. Through decades of innovation and clinical leadership, we have introduced this therapy in more than 90 countries, delivering measurable improvements in patient outcomes. In Europe, HVHDF is now the routine treatment for the majority of our hemodialysis population—a testament to the dedication and collaboration of our clinicians, engineers, and global partners.

Today, we are honored to bring this life-enhancing therapy to people who need dialysis in the United States. In 2024, the U.S. Food and Drug Administration granted 510(k) clearance for our 5008X hemodialysis system. By early 2025, the first HVHDF treatments were successfully delivered in a U.S. Fresenius Kidney Care center. This milestone represents more than technological progress—it marks a clinical breakthrough that offers renewed hope and elevates the standard of kidney replacement therapy.

Yet, innovation alone is not enough. To ensure widespread adoption, we must also invest in education, operational readiness, and policy alignment. That is why we are committed to training clinicians, supporting real-world research, and working closely with stakeholders to integrate HVHDF into practice in a sustainable and equitable way.

This handbook reflects our commitment to knowledge-sharing and to empowering kidney care professionals with the tools and insights needed to deliver the highest quality care.

Thank you for your continued partnership and leadership in advancing dialysis treatment. Together, we are shaping the future of kidney care—one defined by innovation, collaboration, and an unwavering focus on what matters most: better outcomes for people who need dialysis.

Warm regards,

Helen Giza
Chief Executive Officer
Fresenius Medical Care