Carotid Stents
Xact Rapid Exchange Carotid Stent System
Indications for Use
The Xact® Carotid Stent System (Xact®), used in conjunction with the Abbott Vascular Devices embolic protection system is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined below: Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or > 80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intra-cranial segment of the internal carotid artery AND Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion.
Key Specifications
- Delivery system: rapid exchange (RX) system with outer diameter (OD) of 5.7Fr (1.9mm)
- Compatible with 8F guiding catheter or 6F sheath with inner diameter (ID) of 0.088" or greater
- Working length: 136cm
- Installed over 0.014" RX BareWire guide wire
- Stent material: Nitinol (nickel-titanium alloy), self-expanding, cut from Nitinol tube into a flexible tubular prosthesis
- Configurations: tapered and straight
- Unconstrained stent diameters: 6mm to 10mm (straight: 7mm, 8mm, 9mm, 10mm; tapered: 8-6mm, 9-7mm, 10-8mm)
- Stent lengths: 20mm, 30mm, 40mm
- Radiopaque markers at proximal and distal ends of the stent
- Deployment: achieved by rotating the deployment actuator clockwise on the handle
- Sterilization: Ethylene Oxide, single use only
- MRI safe: up to 3-Tesla static magnetic field, maximum temperature increase of 0.6°C
- Foreshortening: >8% during deployment
- Stabilizer works with hemostasis valve to improve placement accuracy
Description
The Xact® Carotid Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is a rapid exchange (RX) system designed to deliver the self-expanding stent to the carotid vasculature. The self-expanding stent is cut from Nitinol tube into a flexible tubular prosthesis. Upon deployment of the stent into the carotid vasculature via the delivery system, the stent should appose the vessel wall and apply an outward pressure to establish patency. The Xact® stent is available in both tapered and straight configurations, with diameters ranging from 6mm through 10mm. Stent lengths range from 20mm through 40mm.