Device Dossier

Pipeline Flex Embolization Device with Shield Technology - Stent, vascular, intracranial

Device Dossier for Pipeline Flex Embolization Device with Shield Technology - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III,…

Intended purpose

The Pipeline Flex embolization device with Shield Technology is intended for endovascular embolization of cerebral aneurysms.

Functional description

The Pipeline Flex with Shield Technology device is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The implant is designed for placement in a parent vessel across the neck of an intracranial aneurysm (IA) and is mounted on a 304 stainless steel micro guidewire approximately 200 cm long and compressed inside an introducer sheath. The device has a surface treatment of phosphoryl-choline to reduce the thrombogenicity of the braid surface.

TGA Public Summary