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FREEWAY™ – CLINICAL PROGRAM

Evidence for the safety and efficacy of the FREEWAY™ 035 DEB in PAD

FREEWAY™ PAD Studies

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FREEWAY Stent Study

Freeway vs. post-stent dilatation with standard balloon with 12 months follow up

FREEWAY™ Δ 16.4% better Primary Patency

  • randomized multicenter trial in Austria and Germany
  • 204 patients with de novo or restenotic lesions that needed stent implantation

 

Main Findings at 12 months follow-up:

 

  1. significantly higher primary patency
  2. clearly lower target lesion revascularization rate
  3. significantly better improvement in Rutherford clinical classifications and proven safety due to low major adverse events rate for patients treated with stent + FREEWAY™ 035 DEB compared to stent + standard balloon PTA.

Study Fyler

PACBUA Trial

Freeway vs. PTA with standard balloon with 12 months follow-up Freeway vs. post-stent dilatation with standard balloon with 12 months follow-up

FREEWAY™ Δ 27.3% better Primary Patency

  • randomized study in Austria
  • 74 patients with in-stent restenosis (DEB group vs. post-stent dilatiation with standard balloon)

 

Main Findings at 12 months follow-up:

 

  1. significantly higher primary patency
  2. clearly lower target lesion revascularization rate
  3. clearly better improvement in Rutherford clinical classifications
  4. proven safety due to low major adverse events rate for patients treated with FREEWAY™ 035 DEB
    compared to standard balloon PTA.

Study Fyler

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Tacke J et al. “The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform
Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and
PI Segment.” Cardiovasc Intervent Radiol 2019 Aug 20. doi: 10.1007/s00270-019-
02309-3.

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Kinstner CM et al. “Paclitaxel-eluting balloon versus standard balloon angioplasty
in in-stent restenosis of the superficial femoral and proximal popliteal artery:
1-year results of the PACUBA trial.” JACC 2016 9(13): 1386-1392.