Pioneering Renal Assist Device: JuxtaFlow's Initial Success
JuxtaFlow Renal Assist Device showed promising physiologic decongestion in the first‑in‑human VOID‑HF trial, increasing 24‑hour urine output and sodium excretion in patients with diuretic resistance.
The VOID‑HF trial was a first‑in‑human, early‑feasibility study in heart failure patients with diuretic resistance that prespecified 24‑hour urine output and sodium excretion as physiologic endpoints.
Unlike standard renal replacement strategies such as ultrafiltration, the device applies controlled negative pressure to the renal pelvis to augment natriuresis while patients remain on diuretics; as an early feasibility effort, the trial prioritized physiologic decongestion markers rather than hard clinical endpoints.
Mean 24‑hour urine output rose from 2.27 L to 3.85 L and mean sodium excretion increased from 78 mmol to 145 mmol—changes consistent with enhanced fluid removal and natriuresis in patients previously resistant to diuretics.
No major adverse events were reported. Observed events included transient hematuria and one reversible episode of reflux anuria; events resolved without lasting harm. Overall tolerability in this small cohort supports further evaluation but requires confirmation in larger studies.
The sponsor plans to expand enrollment into broader, multicenter cohorts to confirm physiologic effects and to power future trials for patient‑centered clinical endpoints. Those steps will determine whether the observed physiologic benefits translate into improved outcomes for patients with cardiorenal decompensation.
Key Takeaways:
- Early feasibility showed JuxtaFlow increased 24‑hour urine output and sodium excretion—suggesting effective decongestion in diuretic‑resistant heart failure.
- Patients with cardiorenal decompensation are the likely initial target population for expanded trials and early clinical use.
- Next steps: larger multicenter feasibility and outcome trials to confirm safety and test whether physiologic gains yield clinical benefit.