Braided Stents
Carotid WALLSTENT Monorail Endoprosthesis
Indications for Use
The Carotid WALLSTENT Monorail Endoprosthesis (Carotid WALLSTENT Endoprosthesis), used in conjunction with the Boston Scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease and meet the criteria outlined below: • Patients with neurological symptoms and ≥50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR patients without neurological symptoms and ≥80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, AND • Patients with a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
Key Specifications
- Closed cell design self-expanding stent composed of biomedical DFT (Drawn Filled Tubing) alloy monofilament wires braided in a tubular mesh configuration
- Wires manufactured from biomedical grade alloy cobalt-chromium-iron-nickel-molybdenum (Elgiloy or Conichrome) with enhanced radiopaque tantalum core
- Delivery system consists of two coaxially arranged shafts: inner shaft (stainless steel proximally, thermoplast distally) and outer sheath (thermoplast)
- Central lumen accepts 0.014 in (0.36 mm) guide wire
- Unconstrained diameters: 6 mm, 8 mm, 10 mm
- Unconstrained lengths: 6 mm (22 mm), 8 mm (21 mm, 29 mm, 36 mm), 10 mm (24 mm, 31 mm, 37 mm)
- Catalog numbers: 71-900, 71-901, 71-902, 71-903, 71-904, 71-905, 71-906
- Working length: 135 cm
- Outer diameter: 5F (0.073 in / 1.85 mm) for 6 mm and 8 mm stents, 6F (0.086 in / 2.18 mm) for 10 mm stents
- Guiding sheath minimum ID: 5F (0.073 in) for 6 mm and 8 mm, 6F (0.086 in) for 10 mm
- Guiding catheter minimum ID: 7F (0.073 in) for 6 mm and 8 mm, 8F (0.086 in) for 10 mm
- Radiopaque markers: two on inner shaft, one on outer sheath
- Holding mechanism allows reconstrainment and repositioning of partially deployed stent (up to 50%)
- Black limit marker indicates maximum deployment for reconstrainment
- Heart shaped hub for product identification
- Implanted lengths vary by vessel diameter: e.g., for 6 mm stent, 30 mm (5 mm vessel), 36 mm (4 mm vessel)
- MRI safe at 3.0 Tesla or less, maximum SAR 2.0 W/kg for 15 minutes (temperature rise ≤1.03°C single, ≤1.72°C overlapped)
- No detectable latex
- Single patient use, sterile by irradiation
- Oversize stent 1-2 mm larger than nominal vessel diameter
Description
The Carotid WALLSTENT Monorail Endoprosthesis is a closed cell design self-expanding stent composed of biomedical DFT alloy monofilament wires braided in a tubular mesh configuration. The wires are manufactured from a biomedical grade alloy cobalt-chromium-iron-nickel-molybdenum (commonly known as Elgiloy or Conichrome) containing an enhanced radiopaque tantalum core. The device has two components: the stent and the stent delivery system (Monorail design with coaxial inner shaft and outer sheath accepting a 0.014 in guide wire).