ELUTAX-SV PACLITAXEL COATED BALLOON …...CORONARY RX Length mm 10 13 15 20 25 30 40 2.00 10200 13200 15200 20200 25200 30200 40200 2.25 10225 13225 15225 20225 25225 30225 2.50 10250

Aachen Resonance Entwicklungsgesellschaft mbH

Pauwelsstrasse 1752074 Aachen | GermanyPhone +49 241 [email protected]

PERIPHERAL FISTULA CORONARY

ELUTAX-SV PACLITAXEL COATED BALLOON CATHETER

ELUTAX-SV the new generation balloon is the first of its kind to integrate two layers for two purposes on the balloon surface.

ORDER-CODE: ELUTAXSV-RX-XXXXXX

REVELATION ELUTAX-SV PERIPHERAL RX ELUTAX-SV

The drug coated balloon to reach lesions

PERIPHERAL RXPurpose Peripheral lesions

Lesion location Femoral a., popliteal a., BTK. aa, plantar

Tip Flexible, soft, 0.017“

Catheter profile Less than 1.1 mm

Catheter design RX

Catheter material Nylon

Usable catheter length Minimum 135 cm

GW length Recommended > 180 cm

Recommended GW 0.014“

Introducer sheath compatibility 4F

Guiding catheter compatibility Minimum 5F

Balloon characteristic Semi compliant

Balloon nominal diameter 1.5-6.0 mm

Balloon nominal length 10-250 mm

Balloon coating 3 layers

Nr. of folds 2-3

Crossing profile Less than 1.2 mm

Inflation time minimal 10 sec

Inflation time recommended 30 sec

Nominal pressure 6 atm

RBP 10-14 atm

Why Dextran?

Dextran is used as protection layer increasing safety. The hydrophilic seal layer improves the balloon lubric-ity and allows to reach the distal lesions without losing its efficacy.

Why Paclitaxel?

Paclitaxel was discovered in the sixties as a result of a U.S. National Cancer program; being isolated from the bark of the Pacific yew.

Paclitaxel is one of several cytoskeletal drugs that target tubulin. Paclitaxel-treated cells have defects in mitotic spindle assembly, chromosome segregation, and cell division. Unlike other tubulin-targeting drugs such as colchicine that inhibit microtubule assembly, paclitaxel stabilizes the microtubule polymer and protects it from disassembly. Chromosomes are thus unable to achieve a metaphase spindle configuration. This blocks progression of mitosis, and prolonged ac-tivation of the mitotic checkpoint triggers apoptosis or reversion to the G-phase of the cell cycle without cell division.

The ability of paclitaxel to inhibit spindle function is generally attributed to its suppression of microtubule dynamics, but recent studies have demonstrated that suppression of dynamics occurs at concentrations lower than those needed to block mitosis. At the higher therapeutic concentrations, paclitaxel appears to suppress microtubule detachment from centro-somes, a process normally activated during mitosis. Paclitaxel binds to beta-tubulin subunits of microtu-bules.

PERIPHERAL RX Length

mm 10 13 15 20 25 30 40 60 80 100 150 200 2501.50 10150 13150 15150 20150 25150 301502.00 10200 13200 15200 20200 25200 30200 40200 60200 80200 100200 150200 200200 2502002.25 10225 13225 15225 20225 25225 30225

2.50 10250 13250 15250 20250 25250 30250 40250 60250 80250 100250 150250 200250 250250

2.75 10275 13750 15275 20275 25275 30275

3.00 10300 13300 15300 20300 25300 30300 40300 60300 80300 100300 150300 200300 250300

3.50 10350 13350 15350 20350 25350 30350 40350 60350 80350 100350 150350 200350

4.00 10400 13400 15400 20400 25400 30400 40400 60400 80400 100400 150400 200400

5.00 20500 30500 40500 60500 80500 100500 150500 200500

6.00 20600 30600 40600 60600 80600 100600 150600 200600 Dia

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Two layer coating for the best outcome

Two layers to create the

4F

ELUTAX-SV

PERIPHERAL OTWPurpose Peripheral lesions

Lesion location ( if not to tortuous) Femoral a., popliteal a., BTK. aa, plantar


Prox. catheter profile 1.3 mm

Catheter design OTW




Max. Recommended GW 0.018“

Introducer sheath compatibility 4F

Guiding catheter compatibility Minimum 5F





Nr. of folds 2-3





RBP 14 (10 atm ≥ 5mm)

PERIPHERAL OTW ELUTAX-SV


ORDER-CODE: ELUTAXSV-OTW-XXXXXX

PERIPHERAL OTWLength

mm 10 13 15 20 25 30 40 60 80 100 150 200 2501.50 10150 13150 15150 20150 25150 301502.00 10200 13200 15200 20200 25200 30200 40200 60200 80200 100200 150200 200200 2502002.25 10225 13225 15225 20225 25225 30225

2.50 10250 13250 15250 20250 25250 30250 40250 60250 80250 100250 150250 200250 250250

2.75 10275 13750 15275 20275 25275 30275

3.00 10300 13300 15300 20300 25300 30300 40300 60300 80300 100300 150300 200300 250300

3.50 10350 13350 15350 20350 25350 30350 40350 60350 80350 100350 150350 200350

4.00 10400 13400 15400 20400 25400 30400 40400 60400 80400 100400 150400 200400

5.00 20500 30500 40500 60500 80500 100500 150500 200500

6.00 20600 30600 40600 60600 80600 100600 150600 200600

7.00 20700 40700 60700 80700

8.00 20800 40800 60800 80800 Dia

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High Pressure:Full Drug Coverage: CORONARY ELUTAX-SV


CORONARY RXPurpose Coronary

Lesion location Coronary


Prox. catheter profile Less than 1.0 mm

Catheter design RX




Recommended GW 0.014“

Introducer sheath compatibility 4F (≥ 7 mm 5F)Guiding catheter compatibility Minimum 5F





Nr. of folds 2-3

Crossing profile Less than 1.2 mm (≤ 6 mm)Inflation time minimal 10 sec



RBP 14 atm

CORONARY RX

Length

mm 10 13 15 20 25 30 402.00 10200 13200 15200 20200 25200 30200 402002.25 10225 13225 15225 20225 25225 302252.50 10250 13250 15250 20250 25250 30250 40250

2.75 10275 13750 15275 20275 25275 30275

3.00 10300 13300 15300 20300 25300 30300 40300

3.50 10350 13350 15350 20350 25350 30350 40350

4.00 10400 13400 15400 20400 25400 30400 40400

ORDER-CODE: ELUTAXSV-RX-CXXXXX

Dia

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4F

High pressure capabilities and short shaft gives safety and comfort

High pressure drug coated balloon

FISTULA OTWPurpose Fistula treatment

Lesion location ( if not to tortuous) Dialysis: AV fistula


Prox. catheter profile 1.3 mm

Catheter design OTW


Usable catheter length Max. 50 cm


Max. Recommended GW 0.018“

Introducer sheath compatibilityMin. 4F for 4-5 mm and 5F 6-7 mm - recommanded 5F



Balloon nominal length 20-40-60 mm


Nr. of folds 2-3





RBP 18 atm

DIALYSIS

Length

mm 20 40 604.00 20400 40400 604005.00 20500 40500 605006.00 20600 40600 60600

7.00 20700 40700 60700

ORDER-CODE: ELUTAXSV-OTWS-XXXXX

Dia

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FISTULA ELUTAX-SV

High Pressure:Full Drug Coverage:

PACLITAXEL TISSUE LEVELS OF DIFFERENT DRUG ELUTING BALLOONS OVER 30 DAYS

Coronary PORCINE ELUTAX-SV Competitor A Competitor B

Uniform coating Yes No No

360 degree Yes No No

Drug dose 1 hourDrug dose 7 daysDrug dose 30 days

~ 250 μmol/ml~ 70 μmol/ml~ 5-10 μmol/ml

~ 200 μmol/ml~ 0 μmol/ml~ 0 μmol/ml

~ 200 μmol/ml~ 10 μmol/ml~ 0.1 μmol/ml

Drug lost during maneuver Max 3% High Up to 30% every 10 sec.

PACLITAXEL - DEXTRAN ELUTAX-SV

Coating technology

Multifunctional top coating SEAL layer 1. Seals the drug at the vessel

2. Therapeutic action time is longer

+ Better mechanical stability + Anti thrombogenic + Lesion protection + Reservoir matrix + Local stability + Lowest wash off after deposition

100 µm

50 µm

20 µm

MULTI PURPOSE DRUG MATRIX WITH PACLITAXEL AND DEXTRAN

• Homogenous coating

• Even and consistent coating of inflated balloons

• Drug matrix (three layers SNOW, ICE and SEAL)

• Balloon with 360 degree coating coverage

• Reliable quantitative drug deposition into the vessel wall

• Target Release Modus (TRM) - drug is released only at minimal 4 bar inflation and contact to vessel wall

• Sustained Value (SV) EFFECT - drug concentration in the vessel wall (intima, media, adventitia) for several weeks

TECHNOLOGY BACKGROUND ELUTAX-SV

Sizes Length from 1 to 25 cm, diameter from 1.5 to 8 mm

Profile reduction "Cut back - technology"

Cross section of homogeneously coated / folded ELUTAX-SV balloon

ELUTAX-SV surface

360 degree coated balloon surface, which consists of 3 layers

SEAL layer of Dextran

SNOW layer of Paclitaxel

(Drug depot)

ICE layer of Paclitaxel

(Elastic stable base)

- The treatment of coronary de novo lesions with ELUTAX-SV Paclitaxel-eluting balloon alone, a pilot study (EXPEL), Dr. S. Eggert Jensen, Aalborg, Dänemark.

- Drug eluting balloon efficacy for small vessel disease treatment, B. Cortese, Mailand, Italien.

- Swedish drug-eluting trial in peripheral arterial disease (SWEDEPAD), Schweden.

- Evaluation of stents versus drug-eluting balloon ELUTAX-SV versus DEB with additional stenting for the treatment of below the knee- critical limb ischemia: a prospective trial.

- A prospective observational study using ELUTAX-SV drug-eluting balloons for below the knee treatment (APOLLO), Dr. Teichgräber, Jena, Deutschland.

- Polish registry angioplasty of infrainguinal arteries using DEB (ELUTAX-SV) – progress.

- Swiss registry with ELUTAX-SV treatment of patients with de novo stenosis or restenosis in a peripheral vessel with ELUTAX-SV 3rd generation.

- Iranian post market register with ELUTAX-SV, controlled use of DEB in coronary arteries – a multicenter study, since 2012, Iran.

- Drug-eluting balloon in restenosis of drug-eluting stents: medium term follow-up.

- DEB in treatment of CLI – single center experience, SUSCCH Banska Bystrica, Slowakei.

- Clinical evidence of ELUTAX-SV in critical limb ischemia, Dr. R. Zahorsky, Hamburg, Deutschland.

- ELUTAX-SV DEB use in hemodialysis fistulas and grafts, Prag, Tschechien.

- Efficacy of the treatment of recurrent stenosis of vascular access with a drug-eluting balloon, Parma, Italien.

- Treating recurrent stenosis in native AV fistulae using the ELUTAX DEB, Northhampton, UK.

- Asian ELUTAX-SV (DCB) for intracranial stenosis trial.

- Analysis of the performance of N-ELUTAX-SV in patients with intracranial stenosis treated in the participating center, Alfred Krupp Krankenhaus, Essen.

- Neuro-ELUTAX-SV in supra-aortic vessels: first results and follow-up, H. Deutschmann, Graz, Österreich.

CLINICAL DATA ELUTAX-SV

- D’Amico, M. and Pennone M., Drug eluting balloon in restenosis of drug-eluting stent: medium term follow up, 2013, Turin, Italien.

- Cortese, B. et al. (2015): “TCT-417 treatment of coronary artery disease with a new-generation drug coated balloon: preliminary results from the Italian ELUTAX-SV registry”.

- Cortese, B. et al. (2015): “Effect of drug-coated balloons in native coronary artery disease left with a dissection”.

- Liistro, F. Porto, I. et al. (2013): “ELUTAX paclitaxel-eluting balloon followed by bare metal stent compared with Xience V drug-eluting stent in the treatment of de novo coronary stenosis: a randomized trial”.

- Ulf Teichgräber et.al (2019): Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Patients with Critical Limb Ischaemia: 1-Year Results of the APOLLO Trial .

- Philip Gruber et.al. (2018): Neuro Elutax SV drug-eluting balloon versus Wingspan stent system in symptomatic intracranial high-grade stenosis: a single-center experience .

- Tolva, V., et al. (2016): “The mid-term clinical follow-up using drug-eluting balloons on tibial artery de novo lesions in patients with critical limb ischemia: a cohort study”.

- Massmann, A. et al. (2015): “Paclitaxel-coated balloon angioplasty for symptomatic central vein restenosis in patients with hemodialysis fistulas".

Documents

ELUTAX-SV PACLITAXEL COATED BALLOON …...CORONARY RX Length mm 10 13 15 20 25 30 40 2.00 10200 13200 15200 20200 25200 30200 40200 2.25 10225 13225 15225 20225 25225 30225 2.50 10250