Device Dossier
Carotid Wallstent Monorail - Prosthesis, internal, stent, vascular
Device Dossier for Carotid Wallstent Monorail - Prosthesis, internal, stent, vascular (Prosthesis, internal, stent, vascular, Class III, sponsor Boston…
- GMDN category: Prosthesis, internal, stent, vascular
Intended purpose
The Carotid WALLSTENT Monorail Endoprosthesis System is intended to improve the luminal diameter of the carotid arteries.
Functional description
The Carotid Wallstent consists of a metal stent pre-mounted on the inner shaft of a monorail delivery system covered by an outer sheath. A guiding catheter with wire is inserted percutaneously & tracked through the vasculature. The device is then back-loaded over the guidewire & positioned at the site of the stenosis with the aid of 2 radiopaque markers. The stent is deployed by sliding back the T Connector & pulling back the outer sheath, allowing the stent to expand & appose the vessel walls.