elutax-sv paclitaxel coated balloon …...coronary rx length mm 10 13 15 20 25 30 40 2.00 10200...
TRANSCRIPT
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
Tip Flexible, soft, 0.02“
Prox. catheter profile 1.3 mm
Catheter design OTW
Catheter material Nylon
Usable catheter length Minimum 135 cm
GW length Recommended > 280 cm
Max. Recommended GW 0.018“
Introducer sheath compatibility 4F
Guiding catheter compatibility Minimum 5F
Balloon characteristic Semi compliant
Balloon nominal diameter 1.5-8.0 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 14 (10 atm ≥ 5mm)
PERIPHERAL OTW ELUTAX-SV
The drug coated balloon to reach lesions
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
The drug coated balloon to reach lesions
CORONARY RXPurpose Coronary
Lesion location Coronary
Tip Flexible, soft, 0.017“
Prox. catheter profile Less than 1.0 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 (≥ 7 mm 5F)Guiding catheter compatibility Minimum 5F
Balloon characteristic Semi compliant
Balloon nominal diameter 2.0-4.0 mm
Balloon nominal length 10-40 mm
Balloon coating 3 layers
Nr. of folds 2-3
Crossing profile Less than 1.2 mm (≤ 6 mm)Inflation time minimal 10 sec
Inflation time recommended 30 sec
Nominal pressure 6 atm
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
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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
Tip Flexible, soft, 0.017“
Prox. catheter profile 1.3 mm
Catheter design OTW
Catheter material Nylon
Usable catheter length Max. 50 cm
GW length Recommended > 110 cm
Max. Recommended GW 0.018“
Introducer sheath compatibilityMin. 4F for 4-5 mm and 5F 6-7 mm - recommanded 5F
Balloon characteristic Semi compliant
Balloon nominal diameter 4.0-7.0 mm
Balloon nominal length 20-40-60 mm
Balloon coating 3 layers
Nr. of folds 2-3
Crossing profile Less than 1.4 mm
Inflation time minimal 10 sec
Inflation time recommended 30 sec
Nominal pressure 6 atm
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
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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".