DRUG ELUTING BALLOON

ELUTAX

Dr. med. Alexander Ruebben

AACHEN RESONANCE FACTS

DEB INDICATIONSCoronary-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

ELUTAX3-D Mirco Structure

ELUTAXLow profile folding technique

ELUTAXTapered flexible tip

Arterial tissue paclitaxel concentration after ELUTAX balloon dilatationproximal reference proximal dilated sequence middle dilated sequence distal distal dilated reference sequence

ELUTAX66,2 79,2 7.0 .

1h1 2 3 4 5

6.9

58,7

1

2

3

4

5

mol/l

proximal reference

proximal dilated sequence

middle dilated sequence

distal distal dilated reference sequence

12h1 2 3 4 5

0,19

9,80

7.79

8,08

0,74

1

2

3

4

5

mol/l

Gyngysi

Pharmacokinetics of Different ConceptsDrug concentration in the tissue micromol/

Data available from Prospect of Manufacturer

l

after contact

0 min

1h

12 h

24 h

48 h

Elutax70 micromol/l

The tissue concentration after one hour seems to be optimal!!!! Gyngysi(tissue concentration of paclitaxel effective from 56 nM to 50 M, toxic effect over 100 M in cell culture, Axel et al. Circulation 1997)

Products with toxic tissue Paclitaxel concentration longer than one hour (tissue concentration of paclitaxeleffective from 56 nM to 50 M, toxic effect over 100 M 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!

ResultsMultiple 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!

UNIVERSITTSKLINIKUM 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!

UNIVERSITTSKLINIKUM 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 ELUTAX2 % 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