DRUG ELUTING BALLOONELUTAX Dr. med. Alexander Ruebben AACHEN RESONANCE FACTS DEB INDICATIONS Coronary-Peripheral-Neurology • • • • • • • • IN-STENT RESTENOSIS BIFURCATIONS SMALL VESSELS OSTIAL LESIONS VERY LONG LESIONS CLOPIDOGREL INTOLLERANCE PLANNED SURGERY AV-Shunts Dialysis ADVANTAGES OF THE NEW TECHNOLOGY • ONE SHOT DRUG APPLICATION • NO TRIGGER TO FOREIGN BODY REACTION DUE TO STENT • NO DISTORTION OF ORIGINAL VESSEL „BIF“ • NO INFLAMATION DUE TO POLYMER • NO MULTIBLE STENT LAYERS IN BIFURCATIONS OR IN-STENT RESTENOSIS • Mixture of Paclitaxel with Hydrophilic and Lipophilic Additive: • Sequent Please - BBraun • In.Pact Amphirion - Invatec WHICH TECHNIQUE IS USED TODAY to Free Paclitaxel and to ensure Uptake • Mixture of Paclitaxel and Shelac solution • DIOR (2nd Gen) - Eurocor • Matrix of pure Paclitaxel „Ice“ and „Snow“ • ELUTAX – Aachen Resonance What does this mean? • A mixture of different compounds with paclitaxel guarantees a diffusion from the balloon and an uptake into the vessel Draw Back!!!! • The release begins once the catheter is in contact with fluids!!!!!!!! • The amount of drug uptake depends on the duration of the procedure! Different Drug Loss of DEB during Intervention Drug-formulation - Pure Drug 0 sec 10 sec 20 sec 30 sec 40 sec 50 sec The SequentPlease loses upto 50% of Drug every 10 seconds The ELUTAX loses max. 10% during the whole procedure Tests were performed together with the Radiology Department, University of Homburg, Prof Buecker, the ELUTAX • • • • • • • • • • Homogenous coating Even and Consistent coating of inflated Balloons Drug Matrix of pure Paclitaxel (two layers SNOW and ICE) Balloon with 360 Degree coating coverage Minimal Drug lost during passage in the body Minimal Drug lost from the balloon surface during maneuver or inflation Reliable quantitative Drug deposition into the vessel wall Safe Drug Transfer No additional substances No Cracks ELUTAX 3-D Mirco Structure ELUTAX Low profile folding technique ELUTAX Tapered flexible tip Arterial tissue paclitaxel concentration after ELUTAX balloon dilatation proximal reference proximal dilated sequence middle dilated sequence distal distal dilated reference sequence ELUTAX 66,2 79,2 7.0 . 1h 1 2 3 4 5 6.9 58,7 1 2 3 4 5 µmol/l proximal reference proximal dilated sequence middle dilated sequence distal distal dilated reference sequence 12h 1 2 3 4 5 0,19 9,80 7.79 8,08 0,74 1 2 3 4 5 µmol/l Gyöngyösi Pharmacokinetics of Different Concepts Drug concentration in the tissue micromol/ Data available from Prospect of Manufacturer l after contact 0 min 1h 12 h 24 h 48 h Elutax 70 micromol/l The tissue concentration after one hour seems to be optimal!!!! Gyöngyösi (tissue concentration of paclitaxel effective from 56 nM to 50 µM, toxic effect over 100 µM in cell culture, Axel et al. Circulation 1997) Products with toxic tissue Paclitaxel concentration longer than one hour (tissue concentration of paclitaxel effective from 56 nM to 50 µM, toxic effect over 100 µM in cell culture, Axel et al. Circulation 1997) Sequent Please Dior current coating Sequent Please Eurocor DIOR new coating Which Problems can occur, if too toxic Drug-levels are applied:? Different aspects: Coating technique • EUROCOR, INVATEC and BBraun, are coating a folded Balloon! • AACHEN RESONANCE coats the inflated balloon See the difference Example for uneven coating: New DIOR BALLOON Totally uneven with big crystals, nearly no Paclitaxel in Folds Opening Behavior of Different Balloons: ELUTAX Multiple Drug Debris are falling of the Balloon during Inflation! Multiple Drug Debris are falling of the Balloon during Inflation! ELUTAX NO Drug Debris are falling of the Balloon during Inflation! Results Multiple Drug Multiple Drug debris are lost debris are lost during Inflation during Inflation Minimal Drug Only partial drug content on inflated load remains on Balloon the Balloon Drug debris may be dangerous causing distal embolism Drug debris may be dangerous causing distal embolism NO Drug lost ! Fully loaded balloon reaches the vessel wall SAFE! UNIVERSITÄTSKLINIKUM DES SAARLANDES New Frontiers: renal artery Treatment of In-stent Restenosis with ELUTAX New Indications Intracranial Application Prof. Reul, Beta Klinik, Bonn 5 Month Angio and MR Follow-up No sign of Restenosis! UNIVERSITÄTSKLINIKUM DES SAARLANDES New Indications Dialysis Shunt Recurrent Stenosis of Brachiocephalic Vein Dialysis Patient 42 years Iasis CE-trial (Bulgaria) In-Stent restenosis, with angiographic follow-up after 6 months: performed by Dr. Ivan Manukov, Head of Department Interventional Cardiology, UMBAL Sveti Georgi Hospital, Plovdiv, Bulgaria 43 patients treated with Elutax 0% restenosis Iasis PE-trial (Bulgaria-Italy) Peripheral USE with color doppler follow-up after 6 months: Carotis, Vertebralis, Subclavia, Renal, AV Fistula, Femoral, BTK, BY Pass graft 39 patients treated with ELUTAX 2 % occlusion 7 % non significant Stenosis THE FUTURE!!! 30-40% OF CORONARY MARKET 90% OF PERIPHERAL MARKET IN THE NEXT 3 TO 4 YEARS ACTUAL DRAW BACK: REIMBURSEMENT-NEW TECHNOLOGY