Flow-Diverting Bifurcation Scaffolds
Exponent Self-Expanding Carotid Stent with Over-the-Wire (OTW) Delivery System
Indications for Use
The Medtronic Vascular Exponent Self-Expanding Carotid Stent with OTW Delivery System, used in conjunction with the Medtronic Vascular embolic protection system, is indicated for improving carotid luminal diameter in 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 either ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by either ultrasound or angiogram, AND 2. Patients having a vessel with reference diameters between 4.5 mm and 9.5 mm at the target lesion.
Key Specifications
- Constructed of nickel titanium alloy (Nitinol)
- Available diameters: 6.0 mm, 7.0 mm, 8.0 mm, 9.0 mm, 10.0 mm
- Available lengths: 20 mm, 30 mm, 40 mm
- Working length of delivery system: 135 cm
- Compatible with 0.014" guidewires and embolic protection devices
- Reference vessel diameters: 4.5-5.5 mm for 6.0 mm stent, 5.5-6.5 mm for 7.0 mm stent, 6.5-7.5 mm for 8.0 mm stent, 7.5-8.5 mm for 9.0 mm stent, 8.5-9.5 mm for 10.0 mm stent
- Compatible introducer sheaths/guiding catheters: minimum inner diameter 0.081" (2.06 mm) for 6.0 mm and 7.0 mm stents, 0.091" (2.31 mm) for 8.0 mm, 9.0 mm, and 10.0 mm stents
- Coaxial over-the-wire delivery system with EZ-Place valve relief, bifurcated luer, strain relief, and three radiopaque marker bands
- MRI Conditional: static magnetic field of 3.0 Tesla or less, spatial gradient field of 720 Gauss/cm or less, maximum whole-body-averaged SAR of 3.0 W/kg for 15 minutes
- Single-use, sterile, e-beam sterilized, do not resterilize
Description
The Medtronic Vascular Exponent Self-Expanding Carotid Stent with Over-the-Wire (OTW) Delivery System is designed to deliver a self-expanding stent to the carotid arteries via a sheathed delivery system. The self-expanding stent is constructed of a nickel titanium alloy (Nitinol), and is compressed and loaded into the delivery system. The stent is delivered to the intended lesion site and then expanded by retraction of a protective sheath and remains as a permanent vessel scaffolding implant. Upon deployment, the stent imparts an outward radial force on the arterial lumen to establish patency.