Drug-Eluting PTA Balloon Technology Specifically designed for peripheral interventions

Drug-Eluting PTA Balloon Technology – Specifically designed for peripheral interventions Balloon Coating FREEWAY™ 035 utilizes an amorphous bioshell coating technology consisting of a 1:1 mixture of paclitaxel and shellac. Paclitaxel Paclitaxel is an active ingredient that inhibits the cell replication thus blocking the microtubules decomposition during the metaphase and anaphase stages of mitosis. Shellac is a natural resin composed of shellolic and alleuritic acid. The excellent film forming properties of shellac are used to coat pharmaceutical products and in the food industry. By selectively...

Drug-Eluting PTA Balloon Technology – Specifically designed for peripheral interventions Various types of PAD indications are associated with the narrowing or occlusion of arterial blood vessels. After predilatation, the FREEWAY™ 035 paclitaxel-eluting PTA balloon catheter is advanced to the lesion site. With the balloon well positioned, inflation for at least 120 seconds releases an optimal amount of the antiproliferative drug. The balloon is withdrawn as the drug penetrates into the artery wall. Paclitaxel acts immediately and efficiently within a short period of time. The shellac coating remains...

Drug-Eluting PTA Balloon Technology -Specifically designed for peripheral interventions 148 Patients in 13 centers in Austria and Germany Nitinolstent + FREEWAY™ DEB post dilatation (n=105) 5 Year Freedom from CD-TLR 5 Year Freedom from all-cause death Month after randomization Significantly reduced need for clinically-driven target lesion revascularization at 5 years (FREEWAY™ 85.3% vs PTA 72.7%, p=0.032) No trend for any accumulation of causes of death in both groups No difference in administered paclitaxel dose in alive vs. died patients No difference in minor or major amputations in both...

Drug-Eluting PTA Balloon Technology – Specifically designed for peripheral interventions Freeway Stent Study 5 FREEWAY™ ∆ 16.4 % Main findings at 12 months follow-up better Primary Patency at 12 months compared to post-stent dilatation with standard balloon Study type and focus • randomized multicenter trial in Austria and Germany • 204 patients with de novo or restenotic lesions that needed stent implantation significantly higher primary patency clearly lower target lesion revascularization rate significantly better improvement in Rutherford clinical classifications and proven safety due to...

Drug-Eluting PTA Balloon Technology – Specifically designed for peripheral interventions Preclinical Program FREEWAY™ 035 DEB Domestic swine femoral arteries (n = 54) underwent percutaneous overstretch balloon dilation, controlled by optical coherence tomography (OCT). Paclitaxel tissue uptake was measured at 1h, 1 and 3 days. • No delay in endothelialization, no disadvantages in injury and inflammation score compared to standard balloon dilatation (femoral arteries 32 ± 2 days). • FREEWAY™ 035 DEB demonstrated safety and efficacy in a preclinical model of overstretch injury in peripheral arteries....

Drug-Eluting PTA Balloon Technology -Specifically designed for peripheral interventions • Wide spectrum of balloon catheters for treating long, diffuse lesions • Elaborated catheter technology with hydrophilic lubricious coating on distal shaft and good crossability, trackability and pushability for treatment of diffuse lesions • Precise, controlled dilatation - Controlled compliance for accurate balloon vessel sizing - Flat balloon shoulders Dual-lumen catheter shaft Single inflation lumen for fast inflation and deflation times kink-resistant shaft material for crossover procedures • Delivers...

Drug-Eluting PTA Balloon Technology -Specifically designed for peripheral interventions Eurocor Tech GmbH In den Dauen 6a, 53117 Bonn Germany [email protected], eurocor.de Eurocor Tech GmbH is a wholly owned subsidiary of Opto Eurocor Healthcare Ltd and is part of the Opto Circuits Group. The device fulfils the requirements for CE marking - Notified Body 1434.