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
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.
Wide Balloon Diameter & Length Range
•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.
Low-Profile Catheter & Multiple Guidewire Compatibility
•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
High Radiopacity for Accurate Placement
•Pt-Ir Markers: Ensures clear, real-time balloon positioning under fluoroscopy, facilitating precise lesion coverage and drug deposition.
Varied Catheter Lengths
•80, 90, 120, 135, 150 cm: Multiple workable lengths allow operators to select the ideal configuration for femoral, popliteal, tibial, or other target vessels.
General Product Specifications
Specification | Detail / Value |
Product Name | Extender Drug PTA Balloon Catheter (Paclitaxel- or Sirolimus-coated, depending on your actual platform) |
Intended Use | 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) |
Guidewire Compatibility | 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) |
Sterility | Sterile (Ethylene Oxide) |
Single Use | Yes |
Shelf Life | 2–3 years if stored at 15–25 °C in sealed packaging |
Clinical Indications | PAD (peripheral artery disease), femoropopliteal lesions, below-the-knee disease, in-stent restenosis in peripheral arteries |
Contraindications | 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) | Product 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) | Product 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 |