Clinical Results

Trial #1: Clinical Feasibility,  2016
Where: Bangalore India: Stage 5

• 12 patients
• No thrombosis, no occlusions, early vein dilation

Trial #2: Efficacy Study 2017
Where: Bangalore India: Stage 5

• 56 patients
• Brescia fistula dilation, No complications or occlusions

FDA Clinical Data Trial – Approved April 2019
Where: FACT @ University of Chicago

• 45 patients, powered study, NSR study
• Vein dilation, safety, compliance, other  – Stage 4 ESRD