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Time to Cannulation: the time between the index procedure to the first successful endoAVF cannulation. N=91.
Outcomes data was pooled in a Global Data Analysis for 91 subjects enrolled in the three 4 Fr Studies. Data was collected from evaluable patients with sufficient follow-up data for the given time point, excluding patients that experienced unrelated deaths or were lost-to-follow up. N=91.
Cumulative cannulation success: Proportion of patients that experienced successful cannulations of the endoAVF with 2-needles for a full dialysis session. Represents evaluable patients at 6 months. Patients were excluded due to lost to follow-up, missed visits and early exits from the study. N=91.
The WavelinQ™ 4F EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.