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.
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.
Clinical Evidence
The Extender drug-eluting balloon has been studied in combination with TemREN atherectomy in lower-extremity arterial disease:
- LEO 7 prospective trial (Journal of Vascular Surgery, 2018) — in 67 patients treated with Temren atherectomy plus Extender drug-eluting balloon, technical success was 97.0% and 6-month freedom from target lesion revascularization was 89.0%. DOI: 10.1016/j.jvs.2018.08.161
Browse the full INVAMED Clinical Evidence Library for source-linked study data.
