Carotid Stents
NexStent® Carotid Stent and Delivery System
Indications for Use
The NexStent® System used in conjunction with FilterWire EZTM Embolic Protection System, is indicated for treatment of patients at high risk for adverse events from carotid endarterectomy (See Section 5 of these instructions) who require carotid revascularization and meet the criteria outlined below: 1. Patients with neurological symptoms associated with ≥50% stenosis of the common or internal carotid artery 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 4mm and 9mm at the target lesion and a stenosis less than 30mm in length.
Key Specifications
- Self-expanding stent for extracranial carotid arteries via sheathed percutaneous delivery system
- Flexible, self-expanding, rolled Nitinol (nickel-titanium alloy) mesh
- Single stent size for vessel diameters 4mm to 9mm
- Stent length: 33mm in delivery system, approximately 30mm deployed at 9mm diameter
- Constrained within 5F (1.66mm) O.D. delivery system
- Over-the-wire (OTW) compatible with 0.014in guidewires
- Delivery sheath: 135cm long, 5 French (0.066in O.D.)
- Compatible with 8F guiding catheter or 6F introducer sheath (minimum I.D. 0.087in / 2.21mm)
- Adapts to straight and tapered vessel anatomies
- Radiopaque markers for positioning
- Deployment via rotating control knob to retract sheath
- MRI safe at field strengths of 3.0 Tesla or less (whole body averaged SAR of 2.0 W/kg and spatial peak SAR of 4.0 W/kg for up to 15 minutes)
- Rapid exchange (Monorail) version compatible with 0.014in or smaller guidewires
- Proximal guidewire exit port at approximately 25cm from distal tip (Monorail)
- Marker bands at 90cm and 100cm from tracking tip (Monorail)
Description
The NexStent® Carotid Stent and Delivery System is designed to deliver a self-expanding stent to the extracranial carotid arteries via a sheathed percutaneous delivery system. The NexStent carotid stent is a flexible, self-expanding, rolled Nitinol (nickel-titanium alloy) mesh. One stent size is used for treating vessel diameters ranging from 4mm to 9mm. The length of the stent is 33mm in the delivery system and is approximately 30mm at a fully deployed diameter of 9mm. The stent is constrained within a 5F (1.66mm) Outside Diameter (O.D.) delivery system. Upon deployment into the carotid vasculature, the stent expands to the vessel diameter, imparting an outward radial force on the vessel wall to establish and maintain vessel patency.