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Safety

Bloodplasma Analysis FREEWAY™ DEB

Paclitaxel blood plasma concentrations

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Paclitaxel blood plasma concentrations at 5, 10, 20 and 60 minutes after inflation (120 sec) with FREEWAY™ DEB. Level of toxicity for paclitaxel plasma concentration calculated with a human body surface area of 1.9 m² and blood plasma content of 3.5l.

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.

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Margolis J et al. “Systemic nanoparticle paclitaxel (nab-paclitaxel) for in-stent restenosis I (SNAPIST-I): a first-in-human safety and dose-finding study.” Clinical cardiology 2007 30(4): 165-170.