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