Danubio is a new generation in drug coated balloon technology.  It offers an innovative and efficient option to treat both complicated and challenging lesions including in-stent restenosis and de-novo lesions in small vessels.  Danubio is also recommended for treatment of the side branch in combination with the Nile Polymer Free Bifurcation DES.

SPECIFICATION

• The BTHC excipient has a lipophilic profile offering enhanced resistance  of coating during the path from catheter to lesion.  The lipophilic property also aids endothelial penetration
• Paclitaxel 2.5μg/mm² has a proven safety and efficacy profile and minimises risk of overdose when using multiple DEBs or DEB + DES during bifurcation treatment
• Automated micro deposition of the drug with a micropipette provides homogenous distribution of paclitaxel on the balloon allowing reduced drug dosage
• 1.5 – 4.0mm balloon diameter sizes available with a length of 10-40mm
• 1.5-3.0mm balloon diameter compatible with 5F guide catheter,  3.5mm balloon diameter compatible with 6F guide catheter and 4.0mm balloon diameter compatible with 7F guide catheter
• Nominal Pressure (NP): 6atm
• Rated Burst Pressure (RBP): 16atm
• Guidewire compatibility: 0.014″

CLINICAL DATA

• The DEBSIDE Trial 6 months clinical results demonstrated a very low TLR rate (2%) in SB.  The angiographic late lumen loss results suggest an absence of neointimal hyperplasia in the SB.
• The DEBREST Trial 6 months angiographic late lumen loss was consistent with previous study results.  The clinical outcome demonstrated very low TLR (5%) and MACE rates (5%).
• Please click here to review ‘Drug eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials’  Andreas Indermuehle, Rahul Bahl, Alexandra J Lansky, et al.  Heart 2013 99: 327-333
• Please click here to review ‘How to use the drug-eluting balloon: recommendations by the German consensus group’ Franz X. Kleber, MD; Detlef G. Mathey, MD; Harald Rittger, MD; Bruno Scheller, MD on behalf of the German Drug-eluting Balloon Consensus Group. EuroIntervention 2011;7:K125-K128