Device Dossier

Acclino® flex plus Stent - Stent, vascular, intracranial

Device Dossier for Acclino® flex plus Stent - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor Compliance Management…

Intended purpose

The device is intended for use with embolisation materials in the treatment of intracranial aneurysms.

Functional description

The device is a self-expanding, laser-cut nitinol stent, preloaded onto a transport wire in an introducer. The tip of the transport wire is J-shaped. The stent features a closed cell design with three radiopaque markers each at the proximal and distal end. To facilitate positioning under the fluoroscopy,the transport wire is also equipped with 3 radiopaque markers.

TGA Public Summary