Elutax World

ELUTAX PACLITAXEL ELUTING BALLOON

Drug eluting Balloons

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

ELUTAX TECHNIQUE • Matrix of pure Paclitaxel „Ice“ and „Snow“ • ELUTAX – Aachen Resonance •

WHICH DIFFERENT TECHNIQUES to Free Paclitaxel and to ensure Up-take • Mixture of Paclitaxel with Hydrophilic and Lipophilic Additive, coated when balloon is folded: • Sequent Please - BBraun • In.Pact – Invatec •

Data from Prospect BBraun and Invatec

• Mixture of Paclitaxel and Shelac Hydrophilic solution, coated when balloon is folded: • DIOR (2nd Gen) – Eurocor

•

Data from Prospect Eurocor

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 reference Balloon was the SequentPlease from BBraun

Arterial tissue paclitaxel concentration after ELUTAX balloon dilatation proxim al dilated sequen ce

proxim al referen ce

1 h

1

middle dilated sequen ce

distal referen ce

6.9 3

2

distal dilated sequen ce

ELUTAX 58,7

12 h

proxim al dilated sequen ce

1

2

middle dilated sequen ce

distal dilated sequen ce

4

7.0 .

2

3

4

5

µmol/l

distal referen ce

0,19 3

79,2

5

4

1

proxim al referen ce

66,2

9,80

7.79

8,08

0,74

5 1

2

3

4

5

µmol/l

Gyöngyösi data submitted for

Pharmacokinetics of Different Concepts Data available from Prospect of Manufacturer

Drug concentration in the tissue

l

micromol/

after contact

0 min

1h

12 h

24 h

48 h

Elutax 70 micromol/l

The tissue concentration after one hour seems to be Gyöngy optimal!!!! ösi

(tissue concentration of paclitaxel effective from 56 nM to 50 µM, toxic effect over 100 µM in cell culture, Axel et al. Circulation 1997)

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