Carotid Stents
RX Acculink Carotid Stent System
Indications for Use
The RX Acculink Carotid Stent System, used in conjunction with the Abbott Vascular embolic protection system specified below, is indicated for the treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below:
Embolic Protection System: With neurological symptoms - High Risk: Abbott Vascular's Accunet or Emboshield Family; 50% stenosis of the common or internal carotid artery by ultrasound or angiogram. Standard Risk: Abbott Vascular's Accunet only; 70% stenosis of the common or internal carotid artery by ultrasound or >50% stenosis of the common or internal carotid artery by angiogram.
Without neurological symptoms - High Risk: Abbott Vascular's Accunet or Emboshield Family; 80% stenosis of the common or internal carotid artery by ultrasound or angiogram. Standard Risk: Abbott Vascular's Accunet only; 70% stenosis of the common or internal carotid artery by ultrasound or 60% stenosis of the common or internal carotid artery by angiogram.
Must be within 4.0 mm - 9.0 mm at the target lesion. Reference vessel diameter 3.0 mm.
Embolic Protection System: With neurological symptoms - High Risk: Abbott Vascular's Accunet or Emboshield Family; 50% stenosis of the common or internal carotid artery by ultrasound or angiogram. Standard Risk: Abbott Vascular's Accunet only; 70% stenosis of the common or internal carotid artery by ultrasound or >50% stenosis of the common or internal carotid artery by angiogram.
Without neurological symptoms - High Risk: Abbott Vascular's Accunet or Emboshield Family; 80% stenosis of the common or internal carotid artery by ultrasound or angiogram. Standard Risk: Abbott Vascular's Accunet only; 70% stenosis of the common or internal carotid artery by ultrasound or 60% stenosis of the common or internal carotid artery by angiogram.
Must be within 4.0 mm - 9.0 mm at the target lesion. Reference vessel diameter 3.0 mm.
Key Specifications
- Self-expanding nickel-titanium (nitinol) stent pre-mounted on a rapid exchange delivery catheter
- Radiopaque markers on the shaft to mark stent location
- Delivery system includes retractable sheath, radiopaque tip, internal guide wire lumen (0.014" compatible), handle assembly with safety lock, and pullback handle
- Stent diameters: 5.0 mm, 6.0 mm, 7.0 mm, 8.0 mm, 9.0 mm, 10.0 mm (unconstrained)
- Stent lengths: 20 mm, 30 mm, 40 mm
- Tapered stent configurations: 6-8 mm taper (ICA 4.3-5.4 mm, CCA 5.7-7.3 mm), 7-10 mm taper (ICA 5.0-6.4 mm, CCA 7.1-9.1 mm)
- Reference vessel diameters: 3.6-9.1 mm
- Stent-to-artery ratio: 1.1:1 to 1.4:1 recommended
- Compatible with 8F guiding catheter (min. ID 0.085"/2.2 mm) or 6F introducer sheath (min. ID 0.085"/2.2 mm), length not exceeding 100 cm
- Compatible with Abbott Vascular's Accunet or Emboshield family of Embolic Protection Systems
- Delivery system dimensions: Proximal shaft 5.9F (1.98 mm), distal shaft 4.4F (1.47 mm) to 5.7F (1.91 mm) to 3.6F (1.19 mm)
- Total length: 132 cm
- MRI conditional: Up to 3.0 Tesla, maximum spatial gradient 3.3 T/m, maximum whole body averaged SAR 2.0 W/kg for 15 minutes
- Single-use, sterilized with electron beam radiation
- Intended for deployment via retraction of pullback handle to uncover and expand the stent
Description
The RX Acculink Carotid Stent System includes a self-expanding nickel-titanium stent pre-mounted on a rapid exchange stent delivery catheter. Radiopaque markers on the shaft mark the stent location. The delivery system is comprised of a retractable sheath covering the stent during delivery, a radiopaque tip, an internal guide wire lumen, a handle assembly with a safety lock, and a pullback handle. Upon deployment, the stent forms an open lattice, providing the scaffolding necessary to hold the artery open and ensure blood flow through the artery.