Device Dossier

silk vista Intracranial self-expandable stent - Stent, vascular, intracranial

Device Dossier for silk vista Intracranial self-expandable stent - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor…

Intended purpose

The self-expandable silk vista and silk vista baby stents are intended for the treatment of intracranial aneurysms.

Functional description

Self-expanding stents in Nitinol and a delivery system. The delivery system is comprised of a delivery wire (pusher) and an introducer. The silk vista or silk vista baby stent is pre-loaded on the delivery wire inside the introducer. Placement of the silk vista or silk vista baby stent requires the use of: A reinforced microcatheter A Y-connector with a valve allowing the introducer tube to be positioned in contact with the microcatheter hub A torquer

TGA Public Summary