Eurocor GmbH

Rheinwerkallee 2D-53227 BonnGermany

Phone: +49 (0) 228 / 20 15 0-0Fax: +49 (0) 228 / 20 15 0-5

info@eurocor.dewww.eurocor.de

Rev No. 0509 B5 DaB354/0805/09

1434

The Eurocor way of science for better patient results.

Interventional Cardiology

Interventional Cardiology

The clinically most effective Solution

in the Treatment of Coronary In-stent

Restenosis.

PACLITAXEL-ELUTING CORONARYBALLOON DILATATION CATHETER

THE PROBLEM: CORONARY IN-STENT RESTENOSIS

1. DIOR. For the benefi t of your patient. It is not an implant!

2. DIOR reduces stent implantation, thus stenting problems.

3. DIOR eliminates the need for any Stent-in-stent re-intervention. The consequences of additional stiffening of the stented artery caused by the stent-in-stent treatment method, are avoided. The previously stented patient, when treated with DIOR remains accessible to re-intervention if needed, without restricting the chance of a successful repeated treatment.

4. DIOR short-term drug elution eliminates long-term drug-associated vessel burden. DIOR promotes rapid healing.

5. DIOR offers the greatest patient benefi t with 1 month of antiplatelet therapy.

6. DIOR may replace stenting by successful, drug-eluting side branch dilatation of bifurcated coronary artery lesion.

7. DIOR promises excellent clinical results with small diameter lesion dilatation without stenting!

DIOR. The new Paclitaxel-eluting coronary balloon dilatation catheter.

• Low-dose drug effectiveness inhibits smooth muscle cell proliferation for the successful treatment of coronary in-stent restenosis. • Signifi cant reduction of the incidence of recurrent

in-stent restenosis. • DIOR ensures high patient safety. • No adverse effects detected.

DIOR ®

Dilatation of Restenosis

Paclitaxel dosage: 3µg /mm² balloon surface area

THE SOLUTION: DIOR DILATATION OF IN-STENT RESTENOSIS

DIOR. TREATMENT OF STENT-ASSOCIATED PATIENT COMPLICATIONS.

• Highly effective drug bioavailability in tissue with a short-term (30 seconds) DIOR dilatation of the coronary artery lesion. • The exclusive bioshell drug matrix enhances the clinically

effective drug transfer from the DIOR balloon surface into the vessel wall.

Uniform (homogenous) artery drug distribution, post DIOR balloon dilatation.

(Displayed under fl uorescent microscopy)

DIOR ®

Dilatation of Restenosis

2.0mm

The New ScienceDilatation of Restenosis.

The Science of DIOR.Histological fi ndings and drug release. Achieved by Eurocor`s exclusive BIOSHELL balloon coating technology.

• The DIOR coating is a mixture of aleuritic & shellolic acid with Paclitaxel• Paclitaxel (Ph.Eur. 5.8) has been known for more than one decade to inhibit restenosis• Shellac (Ph.Eur. 4.0) has a wide usage in the pharmaceutical and food industries• The excellent fi lm forming properties of shellac are used to coat gastric resistant tablets and fruits• The DIOR Bioshell coating matrix consists of a natural raisin, which is EMEA and FDA approved as food additive under E 904• The DIOR drug-coating method is internationally patent pending.

Optimal arterial tissue Paclitaxel concentration is achieved by 30 sec. balloon infl ationInfl ation time-dependent tissue concentrations of Paclitaxel from the DIOR balloon:29 Porcine arteries were treated with the DIOR balloon in a time-dependent matter.Arteries were dissected and send to a blinded laboratory for Paclitaxel determination.

Aleuric Shellac

aleuritic acid (III) shellolic acid (IV)

N=29

Paclitaxel

ce of DIOR

Histological Evaluation in Preclinical SettingPorcine coronary arteries were dilated (1.3:1 balloon/artery ratio) with either DIOR balloon (3 µg/mm2 paclitaxel balloon surface) or non-coated balloon. Follow-up angiography and obduction: 14 days post-balloon dilatation.

2. DIOR: Excellent result. *Healthy neointimal formation.

1. Uncoated balloon dilatation.

*

Excellent late lumen loss results with 0.13 mm neointima thickness

DIOR. Excellent clinical effi cacy and safety.

®

neointima

media

adventitia

Interventional Cardiology

2.00 mm 2.25 mm 2.50 mm 2.75 mm 3.00 mm 3.50 mm 4.00 mm

15 mm Dior 2.00-15 Dior 2.25-15 Dior 2.50-15 Dior 2.75-15 Dior 3.00-15 Dior 3.50-15 Dior 4.00-15

20 mm Dior 2.00-20 Dior 2.25-20 Dior 2.50-20 Dior 2.75-20 Dior 3.00-20 Dior 3.50-20 Dior 4.00-20

25 mm Dior 2.00-25 Dior 2.25-25 Dior 2.50-25 Dior 2.75-25 Dior 3.00-25 Dior 3.50-25 Dior 4.00-25

30 mm Dior 2.00-30 Dior 2.25-30 Dior 2.50-30 Dior 2.75-30 Dior 3.00-30 Dior 3.50-30 Dior 4.00-30

Order Number

Bal

loo

n Le

ngth

Balloon Diameter

DIOR - Product Order Information

Shaft Material Stainless Steel

Balloon Material Polyamide Blend

Usable Catheter Length 140 cm

Max. Recomm. Guide Wire 0.014“

Length of Guide Wire Lumen 25 cm

Tip Length 3.5 mm

Tip Profile 0.016“

Proximal Hypotube 1.8 F

Distal Shaft Diameter 2.6 F

Average Burst Pressure 22 bar

Technical Data

Pressures: Nominal pressure 6 bar / Rated burst pressure 16 bar (at 37°C)

Compliance Chart

International publications:I. Pieter Stella et al., Catheterization and Cardiovascular Interventions, 71:629-635 (2008)II. Aniko Posa et al., Coronary Artery Disease, 19:243-247 (2008)III. Ron Waksman et al., Catheterization and Cardiovascular Interventions, 73:643-652 (2009)IV. Dorothea I. Axel et al., Circulation 1997, Paclitaxel Inhibits Arterial Smooth Muscle Cell Proliferation and Migration In Vitro and In Vivo Using Local Drug Delivery, 96:636-645V. Rembert Pogge v. Strandmann et al., Euro Intervention PCR Supplement (2009)VI. Kostas Spargias et al., JoIC (2009)

Ongoing clinical DIOR trials:I. DIOR dilatation randomized trial (A. Colombo, Multi-Center)II. DEBUIT randomized trial (P. Stella, Bifurcation Study, Multi-Center)III. DEB-AMI randomized trial (P. Stella, Acute myocardial infarct, Multi-Center)IV. DES-ISR Registry (F. Mauri, Multi-Center)V. DIOR-Registry (International Register)

Bar Balloon Diameter mm 1.5Ø 2.0Ø 2.5Ø 3.0Ø 3.5Ø 4.0Ø

2 1.39 1.85 2.32 2.78 3.24 3.71

4 1.44 1.92 2.40 2.88 3.36 3.84

Nominal pressure 6 1.50 2.00 2.50 3.00 3.50 4.00

8 1.54 2.05 2.56 3.07 3.58 4.09

10 1.57 2.09 2.61 3.13 3.65 4.17

12 1.59 2.12 2.65 3.18 3.71 4.24

14 1.62 2.16 2.70 3.24 3.78 4.32

Rated burst pressure 16 1.65 2.20 2.75 3.30 3.85 4.40

18 1.68 2.24 2.80 3.36 3.92 4.48

We think Future

DIOR ®

Dilatation of Restenosis

The New

Exclusive bioshell coating Shiny Paclitaxel appearence by special optical refraction of bioshell coating

Interventional Cardiology