Device Dossier

self expanding nitinol stent LEO+ - Stent, vascular, intracranial

Device Dossier for self expanding nitinol stent LEO+ - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor Balt). ARTG…

Intended purpose

A self exapandable intracranial stent made of Nitinol intended for the treatment of intracranial aneurisms or for the treatment of intracranial stenoses. The stent is deployed into the intracranial vessel via an introducer catheter (VASCO+), which is later removed leaving the expanded stent in place.

Functional description

The LEO+ stent is used for the treatment of intercrancial aneurisms and atherosclerotic stenoses accessible through endovascular tracts. The delivery system kit contains: . 1 self-expanding Nitinol stent LEO+ . 1 delivery catheter Vasco+MP . 1 pusher + 1 introducing tube . 1 Y valve adaptor + 1 torquer

TGA Public Summary