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

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