Extender Medikamentenfreisetzender PTA-Ballonkatheter

Extender Medikamentenfreisetzender PTA-Ballonkatheter

Extender Medikamenteneluierender PTA-Ballonkatheter; A medikamentenbeschichtet Ballon für die periphere transluminale Angioplastie (PTA), Freisetzung antiproliferativ Mittel zur Abschwächung der Restenose in Oberschenkel- oder Kniekehlenarterien.

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Elevating Angioplasty with Precision and Efficacy

  • Balloon Material: Durable and flexible for precise navigation and deployment.
  • Compatibility: Usable with standard catheter systems.
  • Size Range: Available in various sizes to accommodate different vascular diameters.

Choose for Optimal Drug Delivery

  • Deployment: Rapid and controlled balloon inflation and deflation.
  • Drug Type: Paclitaxel Incorporates anti-proliferative drugs to prevent restenosis.
  • Drug Coating: Homogeneous drug distribution for consistent delivery.

Innovation Meets Vascular Treatment

  • Highly compliant balloon material ensures optimal contact with the vessel wall for 
    effective drug delivery.
  • Therapeutic window achieved after 30 seconds inflation time.
  • Rapid drug release and absorption kinetics ensure targeted therapeutic effects,
    assuring physicians of sustained results.

Safety and Effectiveness of the Novel TemREN Atherectomy System Combined Use With Extender Drug-Eluting Balloon in Lower Extremity Arteries

Results

For the primary analysis, the rate of lesion technical success was 97.0%, meeting the prospectively established target performance goal of 86%. After postatherectomy adjunctive therapy, residual stenosis was 30% for 100% of lesions means final diameter stenosis, 10.9%.

Early and midterm results of the retrograde transpopliteal approach as the first-line treatment for total occlusions of iliofemoral arteries.

Results

Technical success, defined as restored patency with no stenosis greater than 30%, was achieved in (92.9%) of patients. A patient who was a heavy smoker showed acute symptoms of claudication due to 80% stenosis of the iliac stent 20 days after discharge and was treated with balloon angioplasty.

  • 3.0-3.5ug / mm2 drug dosage
  • <2mm particles
  • Contrast media as a drug carrier
  • Minimum drug release during delivery
  • Available in Non-Compliant version
  • <90% drug transfer to the target lession
  • Quick deflation time
  • Excellent pushability

Allgemeine Produktspezifikationen

Spezifikation Detail / Wert
Produktname Extender Drug PTA Balloon Catheter (Paclitaxel- or Sirolimus-coated, depending on your actual platform)
Verwendungszweck Percutaneous transluminal angioplasty (PTA) in peripheral arteries (e.g., femoral, popliteal, tibial) to reduce restenosis
Balloon Material Semi-/Non-Compliant polymer (Nylon, Pebax) with drug coating
Drug Coating Paclitaxel or alternative antiproliferative agent (x µg/mm²)
Nominal Inflation Pressure ~6–10 atm (depends on diameter)
Rated Burst Pressure (RBP) ~12–16 atm (depending on balloon size)
Catheter Shaft Length Typically 80–150 cm (adjust for your product line)
Kompatibilität der Führungsdrähte 0.018” or 0.035” (commonly for peripheral balloons—verify actual design)
Coating Release Rapid drug release upon inflation (~30–60 seconds recommended inflation time)
Sterilität Steril (Ethylenoxid)
Einmaliger Gebrauch Ja
Haltbarkeitsdauer 2–3 years if stored at 15–25 °C in sealed packaging
Klinische Indikationen PAD (peripheral artery disease), femoropopliteal lesions, below-the-knee disease, in-stent restenosis in peripheral arteries
Kontraindikationen Highly calcified lesions requiring atherectomy first, allergic reaction to drug coating, severely tortuous or occluded vessels

Diameter Range 1.5–6.0 mm (For smaller vessels, BTK or moderate femoral)

Balloon Dia (mm) Balloon Length (mm) Nominal Pressure (atm) RBP (atm) Drug Load (μg) Produkt-Code
1.5 20 6 12 ~200 EXD-PTA-1.5x20
1.5 40 6 12 ~400 EXD-PTA-1.5x40
2.0 40 7 14 ~600 EXD-PTA-2.0x40
2.0 60 7 14 ~900 EXD-PTA-2.0x60
2.5 80 8 14 ~1200 EXD-PTA-2.5x80
3.0 80 8 14 ~1500 EXD-PTA-3.0x80
3.0 100 8 14 ~1900 EXD-PTA-3.0x100
3.5 100 8 14 ~2200 EXD-PTA-3.5x100
4.0 100 9 16 ~2500 EXD-PTA-4.0x100
4.0 120 9 16 ~3000 EXD-PTA-4.0x120
4.5 120 9 16 ~3400 EXD-PTA-4.5x120
5.0 80 9 16 ~2000 EXD-PTA-5.0x80
5.0 120 9 16 ~3000 EXD-PTA-5.0x120
6.0 80 10 16 ~2200 EXD-PTA-6.0x80
6.0 120 10 16 ~3300 EXD-PTA-6.0x120

Diameter Range 7.0–12.0 mm (For bigger femoral/popliteal or iliac arteries)

Balloon Dia (mm) Balloon Length (mm) Nominal Pressure (atm) RBP (atm) Drug Load (μg) Produkt-Code
7.0 60 8 14 ~2000 EXD-PTA-7.0x60
7.0 80 8 14 ~2600 EXD-PTA-7.0x80
7.0 120 9 16 ~3900 EXD-PTA-7.0x120
8.0 80 9 16 ~3000 EXD-PTA-8.0x80
8.0 120 9 16 ~4500 EXD-PTA-8.0x120
9.0 80 9 16 ~3400 EXD-PTA-9.0x80
9.0 120 9 16 ~5100 EXD-PTA-9.0x120
10.0 80 10 16 ~3800 EXD-PTA-10.0x80
10.0 120 10 16 ~5700 EXD-PTA-10.0x120
12.0 80 10 16 ~4600 EXD-PTA-12.0x80
12.0 120 10 16 ~6900 EXD-PTA-12.0x120
Paclitaxel-Iopromid Coating
  • Optimal Drug Delivery: Rapid paclitaxel release into the vessel wall upon balloon inflation aids in inhibiting neointimal hyperplasia.
  • Stable Surface Layer: The specialized coating formulation resists delamination, ensuring controlled, uniform distribution of the antiproliferative agent.
  • Diameter: 1.5 mm–12.0 mm covers small distal arteries up to larger peripheral segments.
  • Length: 20 mm–220 mm addresses both short, focal lesions and extensive diseased vessel segments—reducing procedural device exchanges.
  • 5F Shaft Design: Minimizes access-site trauma, beneficial for challenging anatomies or smaller access routes.
  • Guidewire Options: Accommodates 0.014”, 0.018”, or 0.035” wires, offering flexibility in diverse peripheral vascular lesions.
  • Pt-Ir Markers: Ensures clear, real-time balloon positioning under fluoroscopy, facilitating precise lesion coverage and drug deposition.
  • 80, 90, 120, 135, 150 cm: Multiple workable lengths allow operators to select the ideal configuration for femoral, popliteal, tibial, or other target vessels.

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