Next-generation dialysis: implantable, wearable, and continuous modalities challenging the 3-day-a-week paradigm

Background Conventional thrice-weekly hemodialysis has anchored end-stage kidney disease care for over 50 years, yet delivers a fraction of native clearance…

Authors

Tariq A.M. Zayan; H.A. Khafagy

Citation

Arab J Nephrol Transplant. 2026;8(3):87–99. doi: 10.4103/AJNT.AJNT_3_26

Abstract

Background Conventional thrice-weekly hemodialysis has anchored end-stage kidney disease care for over 50 years, yet delivers a fraction of native clearance and drives cardiovascular morbidity through solute and volume swings. Refinements in membranes, water purity, and vascular access have not closed the survival gap. The FDA’s 2024 Breakthrough Device Designation for the Nephrodite Holly implantable continuous dialysis system has reignited debate about transcending the 3-day-a-week paradigm. Methods We synthesized peer-reviewed literature, regulatory filings, and trial data on three next-generation modalities: implantable continuous dialysis systems, wearable artificial kidneys, and frequent or home hemodialysis, drawing on FDA documentation with explicit caveats where peer-reviewed evidence was absent. Results The physiological case for transcending thrice-weekly dialysis is robust. Increased frequency improves blood pressure, left ventricular mass, and middle-molecule clearance, though randomized mortality benefit is modest and partly reversed at extended follow-up. Implantable systems (University of California San Francisco Kidney Project, Nephrodite Holly) remain preclinical, with unresolved challenges in biocompatibility, thrombogenicity, infection, and membrane durability. Wearable platforms have shown short-term human feasibility but have stalled commercially after more than 25 years. Frequent home hemodialysis, the most evidence-based alternative, serves fewer than 5% of dialysis patients. Conclusion Next-generation dialysis is neither imminent nor science fiction. Adoption requires regulatory pathways for continuous organ-replacement therapy, reimbursement reform beyond session-based payment, durable solutions to biofouling, and trials with validated continuous-clearance endpoints. The nephrology community must demand evidence proportional to the proposed change and resist conflating Breakthrough Device Designation with clinical readiness.

Next-generation dialysis: implantable, wearable, and continuous modalities challenging the 3-day-a-week paradigm

Authors

Citation

Abstract

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