Braided Stents
Cordis PRECISE Nitinol Stent System
Indications for Use
The Cordis PRECISE Nitinol Stent System used in conjunction with the ANGIOGUARD™ XP Emboli Capture Guidewire 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. I. 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 II. Patients must have a vessel diameter of 4-9mm at the target lesion. The vessel distal to the target lesion must be within the range of 3mm and 7.5mm to allow for placement of the ANGIOGUARD XP Emboli Capture Guidewire.
Key Specifications
- Material: Nitinol (laser-cut from solid tube into fine mesh 'Z' configuration)
- Delivery System: Over-the-wire (OTW) configuration with 5.5F or 6F sheathed systems
- Delivery System Components: Inner shaft with catheter tip and luer hub for 0.018" guidewire, outer sheath with radiopaque markers, Tuohy Borst valve
- Nominal Working Length: 135 cm
- Stent Type: Flexible, self-expanding endoluminal stent
- Stent Deployment: Expands to unconstrained diameter upon release, forms open lattice to maintain arterial patency
- Vessel Sizing: Indicated for vessels 1-2 mm smaller than unconstrained stent diameter
- 5.5F System Sizes: Straight stents 5-8 mm diameter x 20, 30, 40 mm lengths; Tapered stent 6-8 mm diameter x 30 mm length
- 6F System Sizes: Straight stents 9-10 mm diameter x 20, 30, 40 mm lengths; Tapered stents 7-9 mm and 7-10 mm diameter x 30 mm length
- Radial Resistive Force (RRF): Greater than 0.90 N/cm
- Chronic Outward Force (COF): Less than 0.75 N/cm
- Open Area: 83-89% for 5.5F stents, 85-88% for 6F stents
- Foreshortening: 1.2% to 6.2% for 5.5F stents, 4.1% to 8.0% for 6F stents
- MRI Compatibility: Safe and compatible in 1.5 Tesla environment (no temperature increase >1°C, no torque/displacement)
- Sterilization: Ethylene oxide (EtO) to 10^-6 SAL
- Shelf Life: 2 years
- Biocompatibility: Compliant with ISO 10993-1 and FDA guidelines
Description
The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine mesh ('Z' configuration) design. The delivery systems consist mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft terminates distally in a catheter tip and originates proximally in a luer hub designed to accept a 0.018" guidewire. The delivery systems have a nominal working length of 135 cm. The self-expanding PRECISE stent is constrained within the space between the inner shaft and the outer sheath, located between distal and proximal stent markers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2mm smaller in diameter than the unconstrained diameter of the stent.