DRUG ELUTING BALLOON

ELUTAX

Dr. med. Alexander Ruebben

AACHEN RESONANCE FACTS

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

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 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 Data unpublished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

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

ELUTAX3-D Mirco Structure

ELUTAXLow profile folding technique

ELUTAXTapered flexible tip

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

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

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

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

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)

Sequent Please

Eurocor DIOR new coating

Which Problems can occur, if too toxic Drug-levels are applied:?

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 % occlusion7 % non significant Stenosis