Safety

Bloodplasma Analysis DIOR® DEB


Paclitaxel blood plasma concentrations

1
2

Paclitaxel blood plasma concentrations at 5 and 10 minutes after infl ation (60 sec) with DIOR® DEB. After inflations of 45 sec or less no paclitaxel could be detected in the blood plasma. 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.

Dior


1

Pósa A., et al. Optimization of drug-eluting balloon use for safety and effi cacy: Evaluation of the second generation paclitaxel-eluting DIOR-balloon in porcine coronary arteries. CCI 2010; 76(3):395-403

2

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.