LEO+ Baby - Stent, vascular, intracranial

Intended purpose

The self-expandable LEO+Baby stent is designed for the treatment of intracranial aneurysms in association with embolization coils and should be used only by clinicians trained in the placement of intracranial stents.

Functional description

The LEO+Baby stent deployment system requires the use of: A self-expanding Nitinol stent and a delivery system. The delivery system is comprised of a delivery wire an introducer and a Torquer. The Self-Expanding Stent is preloaded on the delivery wire inside the introducer. A reinforced catheter for placement and A Y-connector with valve to enable the introducer to be positioned in contact with the hub of the micro catheter and for continuous flushing are not included in the Leo+Baby packaging.