Device Dossier

LVIS - Intraluminal Support Device - Stent, vascular, intracranial

Device Dossier for LVIS - Intraluminal Support Device - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor Life…

Intended purpose

The device is an intraluminal support device (stent) intended for use with embolic coils for the treatment of intracranial neurovascular diseases. The device is also intended to be used in the peripheral vasculature.

Functional description

The device is a self-expanding nickel titanium, single wire braid, compliant, closed-cell design that can be deployed and retrieved by a single operator. The device is packaged sterile as a single unit with an introducer sheath and a detachable push wire.

TGA Public Summary