Carotid Stents
ACCULINK™ Carotid Stent System
Indications for Use
The ACCULINK™ Carotid Stent System and the RX ACCULINK™ Carotid Stent System, used in conjunction with Guidant carotid embolic protection systems, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. 1. Patients with neurological symptoms and ≥50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and ≥80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND 2. Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
Key Specifications
- Material: Nickel-titanium (superelastic at body temperature)
- Stent design: Series of serpentine rings connected at 3 locations around the circumference, aligned along the length and positioned 120 degrees from each other; rings nest within adjacent rings
- Straight configurations: Diameters 5.0 mm to 10.0 mm; lengths 20 mm, 30 mm, 40 mm
- Tapered configurations: 6.0-8.0 mm and 7.0-10.0 mm diameters; lengths 30 mm, 40 mm
- Delivery system: Tracked over 0.014” guide wire in coaxial configuration; radiopaque markers at proximal and distal ends for placement
- ACCULINK™ system: Over-the-wire configuration; sheath retraction deploys stent from distal to proximal
- RX ACCULINK™ system: Rapid-exchange version; guide wire passes through distal 22 cm; otherwise identical to ACCULINK™
- Single-use device
- MRI compatibility: Safe at 3.0 Tesla or less, maximum spatial gradient 3.3 T/m, SAR 2.0 W/kg for 15 minutes
- Stent-free area: 80% to 90% for 5 mm to 10 mm diameters
- Length change during expansion: 1.87% to 3.8% for 10 mm diameter stents
- Radial force and crush resistance: Meets specifications for expansion effectiveness and patency
- Deployment force: 3.45-8.00 N (OTW) and 2.22-4.00 N (RX) at 2 years
- Deployment accuracy: 0.0-2.5 mm (OTW) and 0.0-2.0 mm (RX)
Description
The ACCULINK™ Carotid Stent is a nickel-titanium, self-expanding stent that is superelastic at body temperature. The stent design is based upon a series of serpentine rings that are connected at 3 locations around the circumference. The connections are aligned along the length of the stent and are positioned 120 degrees from each other. The serpentine rings are designed to nest within adjacent rings. The ACCULINK™ Carotid Stent System is a single-use device that uses a sheath to mechanically constrain the ACCULINK™ Carotid Stent at a small diameter for delivery to the treatment site. The system is inserted through a guide catheter or sheath and tracked over a 0.014” guide wire in a coaxial, over-the-wire configuration. Radiopaque markers, located on the delivery system at the proximal and distal ends of the stent, aid in accurate placement of the stent in the lesion. With the handle in the unlocked position, retracting the pullback handle withdraws the sheath and deploys the ACCULINK™ Stent. The stent expands at body temperature, from the distal to the proximal end as the sheath is retracted. The RX ACCULINK™ Carotid Stent System, a rapid-exchange version of the ACCULINK™ System, also uses a sheath to mechanically constrain the same ACCULINK™ Stent. The system is inserted through a guide catheter or sheath, and is tracked over a 0.014” guide wire that passes through the coaxial, distal 22cm of the system. All other features of the System are the same as the ACCULINK™ Carotid Stent System.