Braided Stents
Roadsaver™ Carotid Stent System
Indications for Use
The Roadsaver Carotid Stent System, when used in conjunction with the Nanoparasol™ Embolic Protection System (EPS), is indicated for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy and meet the criteria outlined below: 1. Patients who have either de novo atherosclerotic or post endarterectomy restenotic lesion(s) in the internal carotid arteries or at the carotid bifurcation with ≥50% stenosis if symptomatic or ≥80% stenosis if asymptomatic (both defined by angiography), AND 2. Patients having a vessel with reference diameters between 3.5 mm and 9.0 mm at the target lesion.
Key Specifications
- Self-expanding Nitinol stent with dual-layer braided closed cell design
- Outer layer: woven closed cell structure with flared ends
- Inner layer: braided closed cell structure with micromesh sized pores
- Material: nickel titanium (Nitinol)
- Delivery system: 5 French Rapid Exchange (RX) catheter, 143 cm length
- Available diameters: 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm
- Available dual layer lengths: 16 mm to 40 mm
- Vessel diameter range: 3.5 mm to 9.0 mm
- Foreshortening during deployment: 6-28% depending on diameter and length
- Catalog numbers: RDS-0520-143RX, RDS-0530-143RX, RDS-0540-143RX, RDS-0616-143RX, RDS-0625-143RX, RDS-0630-143RX, RDS-0718-143RX, RDS-0725-143RX, RDS-0730-143RX, RDS-0820-143RX, RDS-0825-143RX, RDS-0830-143RX, RDS-0840-143RX, RDS-0920-143RX, RDS-0930-143RX, RDS-1020-143RX, RDS-1030-143RX
- Intended for use with Nanoparasol™ Embolic Protection System (EPS)
- MR Conditional: Safe under 1.5T and 3T conditions with specified parameters
Description
The Roadsaver™ Carotid Stent System consists of a self-expanding Nitinol stent with a dual-layer braided closed cell design and a 5 French Rapid Exchange delivery catheter. The outer layer is a woven closed cell structure with flared ends, and the inner layer is a braided closed cell structure with micromesh sized pores. The stent expands to a pre-determined diameter upon deployment from the 143 cm delivery catheter at the target lesion, conforming to the vessel lumen. It is designed for use with the Nanoparasol™ Embolic Protection System.