Next Generation of DCB: Efficacy and tolerance of drug-coated hyper-compliant balloons (DCHCB) in peripheral arteries of swine

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1 Next Generation of DCB: Efficacy and tolerance of drug-coated hyper-compliant balloons (DCHCB) in peripheral arteries of swine Maciej Kusmierczuk 1 ; Stephanie Bienek, PhD 1 ; Sebastian Schurmann 1 ; Antje Mittag 2 ; Ulrich Speck, PhD 3 ; Bruno Scheller, MD 4 1 InnoRa GmbH, Berlin, Germany 2 IMTR GmbH, Rottmersleben, Germany 3 Experimental Radiology, Charité University Hospital, Berlin, Germany 4 Internal Medicine III, University of Saarland, Homburg/Saar, Germany

2 Disclosure Speaker name: Maciej Kusmierczuk I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

3 Background Local drug delivery by DES or DCB reduces restenosis Irregular lumen diameter in stenotic vessels long vessel segments after predilatation, atherectomy orstenting DCHCB adjust to different vessel diameters Aim Explore inhibition of excessive neointimal proliferation by low pressure inflation of DCHCB Methods Porcine model of injury-induced neointimal proliferation of iliac/ femoral arteries Comparison to standard DCB

4 Results A B C D Porcine iliac/ femoral arteries Hyper-compliant balloon inflated at 0.7 atm PTA balloon, 4.0 mm inflated at 6 atm PTA balloon, 6.0 mm inflated at 6 atm

5 Property Drug-coated hyper-compliant balloon Comparison physical characteristics and drug transfer Drug-coated standard PTA balloon Balloon type Hyper-compliant Non- or semi-compliant Before inflation Contracted Folded After deflation Contracted to its original state Irregular shape of folds Inflation pressure < 1.5 atm High pressure (6-16 atm) Surface area upon inflation Significantly increased Almost unchanged Shape and diameter Drug loss during passage through introducer sheath, % of dose Drug transfer to the vessel wall, % of dose Residual drug on balloons, % of dose Conformable, diameter: 3-12 mm Cylindrical, defined diameter 18.0± ± ± ±6.1 27±14 9.6±8.7

6 Efficacy: OCT of vessel segments 4 weeks after overstretch and stenting plus treatment A uncoated balloon, thick neointimal layer above stent struts D B coated balloon, full lumen maintained C D Treatment with uncoated HCB Treatment with coated DCHCB

7 Standard DCB and DCHCB in inhibition of neointimal proliferation in porcine internal iliac arteries Measurement Drug-coated hypercompliant balloon Angiography Drug-coated standard PTA balloon Lumen-stent distance [mm] 0.27±0.29** 1.13±0.71 OCT Stenosis area [%] 11.6±6.9* 17.1±6.0 Neointimal thickness [mm] 0.09±0.05* 0.12±0.04 Neointimal area [mm 2 ] 0.78±0.42* 1.12±0.39 Histomorphometry Neointimal area [mm 2 ] 2.39±0.55* 3.21±0.76 Diameter stenosis [%] 16.4±3.5* 20.9±5.5 Area stenosis [%] 29.3±5.8* 35.8±7.2 * significant versus uncoated ** significant versus coated and uncoated PTA

8 Summary Same inhibition of neointimal proliferation as drug-coated PTA balloon but fully compliant a single balloon for all vessel diameters including bifurcations

9 Conclusions After adequate vessel preparation and/ or stenting drug-coated hyper-compliant balloon catheters may allow for homogenous treatment of irregularly shaped vessel segments and long segments with variable diameters.