Press Release   -

Fresenius Medical Care Revolutionizes Dialysis Treatment with FDA Clearance for 5008X Hemodialysis System

Fresenius Medical Care (FME), a global leader in renal disease solutions, proudly announces the receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its groundbreaking 5008X Hemodialysis System. This milestone empowers FME to introduce a new standard of care in dialysis therapy to patients battling kidney diseases in the U.S.

Dialysis is a vital lifeline for patients with renal failure, which allows the removal of excess water, solutes and toxins from the blood stream. Unlike traditional high-flux hemodialysis, the high-volume hemodiafiltration offered by the 5008X system employs both diffusion and convection techniques, effectively managing fluid replacement and eliminating larger molecules.

A groundbreaking development in dialysis research has been demonstrated by recent CONVINCE study, which showed a remarkable 23% mortality reduction for patients treated with High Volume Hepaodiafiltration versus conventional methods of treatment. The effectiveness of this innovative approach is highlighted by a multinational study carried out over 3 years at 61 dialysis centers in 8 Member States.

Set for clinical evaluations and user studies in the U.S. with a targeted market launch in 2025, the 5008X Hemodialysis System represents the pinnacle of Fresenius Medical Care's medical device innovations. Alongside the FX CorAL dialyzer, already approved in the U.S., this system integrates cutting-edge device engineering and membrane technologies essential for high-volume hemodiafiltration. In the U.S., approximately 160,000 in-center hemodialysis machines across service providers could potentially adopt this new standard of care, signaling a significant advancement in dialysis treatment.

Fresenius Medical Care is committed to developing the landscape of dialysis treatment, using its expertise in medical devices and membrane engineering with a view to improving patients' outcomes and quality of life for people all over the world.

According to analysts at Vantage Market Research, the Dialysis market is anticipated to achieve USD 206 Billion by 2032 with a CAGR of 8.6%. Market dynamics are driven by the growing prevalence of kidney failure, attributed to factors such as the rising incidence of chronic kidney disease (CKD) and aging populations globally. The demand for dialysis services is propelled by the increasing incidence of acute kidney injury (AKI) cases necessitating short-term dialysis interventions and the chronic management of end-stage kidney disease (ESKD), where dialysis becomes a lifelong necessity in the absence of a kidney transplant. 

Moreover, advancements in dialysis technology, including improved dialysis machines, dialyzers, and catheters, continually enhance treatment efficiency, patient comfort, and outcomes.

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