Download - Drug Eluting Balloon
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DRUG ELUTING BALLOON
ELUTAX
Dr. med. Alexander Ruebben
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AACHEN RESONANCE FACTS
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WHICH TECHNIQUE IS USED TODAYto Free Paclitaxel and to ensure Up-take
• Mixture of Paclitaxel with Hydrophilic and Lipophilic Additive:
• Sequent Please - BBraun• In.Pact Amphirion - Invatec
• Mixture of Paclitaxel and Shelac solution• DIOR (2nd Gen) - Eurocor
• Matrix of pure Paclitaxel „Ice“ and „Snow“• ELUTAX – Aachen Resonance
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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!
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Different Drug Loss of DEB during InterventionDrug-formulation - Pure Drug
The SequentPlease loses upto 50% of Drug every 10 secondsThe ELUTAX loses max. 10% during the whole procedureTests were performed together with the Radiology Department, University of Homburg, Prof Buecker, the reference Balloon was the SequentPlease from BBraun against ELUTAX from Aachen Resonance. Data unpublished
0 sec 10 sec 20 sec 30 sec 40 sec 50 sec
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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
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ELUTAX3-D Mirco Structure
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ELUTAXLow profile folding technique
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ELUTAXTapered flexible tip
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12h 0,19 9,80 7.79 8,08 0,74
proximalreference
proximaldilatedsequence
distalreference
middledilatedsequence
distaldilatedsequence
1 2 3 4 5
1 2 3 4 5µmol/l
Arterial tissue paclitaxel concentration after ELUTAX balloon dilatation
1h 6.9 58,7 66,2 79,2 7.0.
proximalreference
proximaldilatedsequence
distalreference
middledilatedsequence
distaldilatedsequence
1 2 3 4 5
1 2 3 4 5 µmol/l
ELUTAX
Gyöngyösi
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Pharmacokinetics of ELUTAX
1 min 60 min 12 hours
Dior 1 gen.
Elutax 2nd gen.For at least 12 hours we have a therapeutic dose in the vessel wall!
Gyöngyösi
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Pharmacokinetics ofDifferent Concepts
after contact 0 min 1 h 12 h 24 h 48 h
Drug concentration in the tissue
micromol/lData available from Prospect of Manufacturer
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ElutaxElutax
The tissue The tissue concentration after one concentration after one hour seems to be hour seems to be optimal!!!!optimal!!!!
(tissue concentration of paclitaxel effective from 56 nM to 50 µM, toxic effect over 100 µM in cell culture, Axel et al. Circulation 1997)
70 micromol/l70 micromol/l
Gyöngyösi
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Products with toxic tissue Paclitaxel concentration longer than one hour
Sequent PleaseDior current coating
(tissue concentration of paclitaxel effective from 56 nM to 50 µM, toxic effect over 100 µM in cell culture, Axel et al. Circulation 1997)
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Sequent Please
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Eurocor DIOR new coating
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Which Problems can occur, if too toxic Drug-levels are applied:?
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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
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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 % occlusion7 % non significant Stenosis