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…

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.

TGA Public Summary