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,…
- GMDN category: Stent, vascular, intracranial
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.