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Safety

FREEWAY™ Preclinical Program

 

Domestic swine femoral arteries (n = 54) underwent percutaneous overstretch balloon dilation with the Freeway™ 035 DEB, controlled by optical coherence tomography (OCT). Paclitaxel tissue uptake was measured at 1h, 1 and 3 days.

Minimum Lumen Diameter (mm)

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Minimum lumen diameter of femoral arteries at baseline and 32 days follow-up. FREEWAY™ 035 DEB inhibited fibrin accumulation in the intima and media, leading to significantly less constrictive remodeling and reduced neointimal hyperplasia of the injured vessel compared to uncoated balloons.

Lumen Diameter Freeway

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Pavo N et al. “Coating of intravascular balloon with paclitaxel prevents constrictive remodeling of the dilated porcine femoral artery due to inhibition of intimal and media fibrosis.” J Mater Sci Mater Med 2016 27(8): 131.

Area Stenosis (mm²) at FU

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Vessels treated with FREEWAY™ 035 DEB show significantly lower area of stenosis in at 32 days follow-up compared to uncoated balloon treatment.

Area Stenosis Fw

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Pavo N et al. “Coating of intravascular balloon with paclitaxel prevents constrictive remodeling of the dilated porcine femoral artery due to inhibition of intimal and media fibrosis.” J Mater Sci Mater Med 2016 27(8): 131.

Tissue paclitaxel concentration (ng/mg) Inflation time 120s

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Inflation of 120s with FREEWAY™ DEB leads to long presence and high concentration of paclitaxel in the arterial wall – crucial for inhibition of neointimal proliferation and restenosis.

Tissue Paclitaxel Fw

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Pavo N et al. “Coating of intravascular balloon with paclitaxel prevents constrictive remodeling of the dilated porcine femoral artery due to inhibition of intimal and media fibrosis.” J Mater Sci Mater Med 2016 27(8): 131.