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FREEWAY™ 035 AV SHUNT – CLINICAL PROGRAM

Evidence for the safety and efficacy of the FREEWAY™ Shunt DEB in AV lesions

German AV Registry

1

Overview

  • 22 hemodialysis patients
  • Follow-up results (N=18)
  • Very low re-intervention rate of only 11%

Access Type

  1. Cimino: 30.3%
  2. basilic: 6.1%
  3. cephalic: 18.2%
  4. AV-Graft: 45.5%
1

Duda S et al. “First experience with DCB in AV-fi stulas.” Presentation at LINC 2015

Italian AV Registry

2

Overview

  • 27 hemodialysis patients
  • Follow-up results (N=27)
  • Significantly longer time to re-intervention after FREEWAY™ 035 DEB treatment compared to standard balloon angioplasty
  • Time to re-intervention: FREEWAY™ 7.6 months vs. 4.8 months standard balloon; p<0.001

Access Type

  1. distal: 29.6%
  2. mid-arm: 11.1%
  3. proximal: 59.2%
2

Troisi N et al. “Freeway paclitaxel-releasing balloons to treat recurrent stenosis of arteriovenous fi stula in hemodialysis patients.” Minerva cardioangiologica 2018 66(3): 233-237.

Turkish AV Registry

3

Overview

  • 52 hemodialysis patients
  • Follow-up results (N=52)
  • Significantly higher primary patency rate at 12 months follow-up and
    significantly longer mean fistula survival time for patients treated
    with FREEWAY™ 035 DEB
  • Primary patency: FREEWAY™ 65.4% vs. 34.6% standard balloon; p<0.05
  • Fistula survival: FREEWAY™ 9.81 months vs. 7.58 months standard balloon; p<0.05

Access Type

  1. radiocephalic: 78.8%
  2. brachiocephalic: 21.2%
3

Çildagˇ MB et al. “The primary patency of drug-eluting balloon versus conventional balloon angioplasty in hemodialysis patients with arteriovenous fistula stenoses.” JPN J Radiol 2016 34(10): 700-704.

Turkish AV Registry II

4

Overview

  • 96 hemodialysis patients (32 FREEWAY™ AV Shunt – 64 PTA)
  • Retrospective Study
  • Significant higher Primary Patency at 6 months: 96.9% DEB vs 20.3% PTA p<0.001
  • At 9 months 66.8 DEB vs 20.3% PTA
  • Longer Median Fistula survival after treatment compared to standard Balloon PTA 220 days vs. 152.5 days
  • Lesser recurrence of fistula dysfunction 21.9% vs 31.3% compared to PTA

Access Type

  1. radiocephalic: 78.8%
  2. brachiocephalic: 21.2%
4

Yildiz, I. et.al (2019). The Efficacy of Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Balloon Angioplasty in Stenosis of Native Hemodialysis Arteriovenous Fistulas: An Analysis of Clinical Success, Primary Patency and Risk Factors for Recurrent Dysfunction. Cardiovascular and interventional radiology, 42(5), 685-692.