Description of the First Hemodialysis Patients Treated with the Moda-flx Hemodialysis System

Background: Hemodialysis device designs primarily focus on functionality, design and the potential for improving the lives of patients impacted by kidney disease. The Moda-flx Hemodialysis System® was cleared for professional use in August 2024. Designed with an integrated reverse osmosis (RO) water purification system and widest dialysis flow rate (DFR) range for clinical flexibility. Here we describe our patient cohort from an in-center setting. Methods: We collected demographics from 12 patients who underwent a total of 41 treatments on the system. Four treatments per patient for 3 days per week (MWF), 4-hour duration, 600 mL/min DFR, mean BFR 380 mL/min and Optiflux F160 and F180 dialyzers. Patients were treated on the RO loop or tap water. Dialysate concentration were prescribed at the discretion of nephrologist. Pre and post samples were drawn for Single Pool Kt/V (SpKt/V) and Urea Reduction Ratio (URR). Results: The mean patient age was 60.58 years old. Demographic data was 66.67% Hispanic, 16.67 % Asian, 8.33 % Caucasian, 8.33 % African American. There were twelve participants, 58.33% males and 41.67% females. Participants access types included 58.3% treated utilizing a fistula, 8.33% treated with an AV graft and 33.3% treated with central venous catheters. (Table 1) Two participants completed one treatment and one participant completed 3 treatments. The mean SpKt/V = 1.3 and URR = 66.1. Conclusion: Early results suggest newer innovative dialysis systems are being designed to meet the needs of a growing diverse patient population. The Moda-flx device is the first to have an integrated RO water purification system to treat with tap water or on the loop and the widest dialysate flow rates (100-600 mL/min Qd). This allows the treatment of a more diverse population while achieving clinical targets. Funding: Commercial Support - Diality