The V012 clinical study is designed to demonstrate the efficacy and safety of the ATEV as a dialysis access method compared to autologous AV fistula in female dialysis patients, a high-unmet-need population. V012 is a Phase 3, prospective, multi-center, open label, randomized, two-arm comparative study conducted in the United States in up to 150 patients, with 120 patients are currently enrolled. The primary measure of efficacy is total days free from in-dwelling catheter ("catheter-free days") until 365 days after access placement, or until access abandonment, whichever occurs first. A prespecified interim analysis was conducted after the first 80 patients enrolled had completed 12 months of follow-up. In this analysis, patients implanted with the ATEV achieved an average of 220 catheter-free days compared to 129 catheter-free days for patients who received an AV fistula. The result was statistically significant (p=0.00070), meeting the primary endpoint of the study.