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Drug coated balloons have been developed to address some of the shortcomings of stents as implantable prostheses in peripheral vascular intervention. The biological profile and efficacy of DCB are strongly related to the formulation of the coating. This study conducted pharmacokinetic, safety and efficacy studies to characterize the paclitaxel (PTX) balloon coating of the Eurocor FREEWAY DCB.
Methods and Results
Forty-two domestic swine underwent percutaneous FREEWAY overstretch balloon dilation for 1 and 2 minutes of both femoral and iliac (4-5 and 6-8 mm diameter, respectively) arteries. Tissue paclitaxel concentrations and the vascular function were measured at 1h, 1, 3 and 9 days. Neointimal hyperplasia (NH) was quantified by computerized planimetry 5 weeks post-DCB use in a (DCB vs. non-coated control balloon) pre-clinical study. The peripheral artery tissue drug levels were 141.9±37.9 vs. 566.3±179.9, 43.2±13.6 vs. 149.4±71.8, 23.4±8.4 vs. 30.0±16.6 and 3.2±2.4 vs. 4.0±1.1 ng/mg using 1 vs. 2 minutes balloon inflation time at 1h, 1, 3 and 9 days post-DCB use, respectively. The NH was significantly smaller in the arteries dilated with FREEWAY compared with control balloon. DCB led to impairment of endothelium-dependent vasodilation in a tissue PTX dose-dependent manner.
In a pre-clinical porcine model, PTX tissue concentration from the FREEWAY DCB is directly related to time of balloon inflation. DCB reduced the NH in peripheral arteries compared to uncoated balloons. Vascular function impairment was directly related to tissue PTX concentration.