Carotid Stents
Protégé GPS Carotid Stent System
Indications for Use
The Protégé GPS Carotid Stent System, when used in conjunction with the ev3 embolic protection systems, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the criteria outlined below: 1. Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography) of the common or internal carotid artery, AND 2. Patients must have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion.
Key Specifications
- Self-expanding Nitinol stent system for permanent implantation
- Stent material: nickel-titanium alloy (Nitinol)
- Stent design: cut from Nitinol tube in open lattice design
- Radiopaque markers: tantalum at proximal and distal ends of stent
- Delivery system: 6 Fr, 0.014"/0.018" over-the-wire
- Delivery components: inner sheath (nylon shaft with flexible catheter tip), outer sheath, safety lock, proximal hub, two radiopaque markers on inner sheath (distal and proximal to constrained stent), Y-adaptor, stopcock, four contrast exit ports on outer sheath, distal marker on outer sheath
- Tapered stents: additional radiopaque marker for diameter transition, mounted with smallest diameter distally
- Deployment: outer sheath retraction by pulling distal grip toward proximal grip; complete when outer sheath marker is proximal to inner sheath proximal marker
- Stent sizes - straight: diameters 6 mm (lumen 4.5-5.5 mm), 7 mm (5.5-6.5 mm), 8 mm (6.5-7.5 mm), 9 mm (7.5-8.5 mm), 10 mm (8.5-9.5 mm); lengths 20, 30, 40, 60 mm
- Stent sizes - tapered: 8-6 mm ((6.5-7.5)-(4.5-5.5) mm lumen), 10-7 mm ((8.5-9.5)-(5.5-6.5) mm lumen); lengths 30, 40 mm
- MR Conditional: up to 3 Tesla, SAR 3 W/kg for 20 min; temperature rise <0.54°C; no migration expected
- Sterilization: Ethylene Oxide; single use only
- Storage: dry, dark, cool place
Description
The Protégé GPS Carotid Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel-titanium alloy (Nitinol) and comes pre-mounted on a 6 Fr, 0.014"/0.018" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and is designed with tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency.