Device Dossier
Pipeline Flex Embolization Device - Stent, vascular, intracranial
Device Dossier for Pipeline Flex Embolization Device - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor Medtronic). ARTG…
- GMDN category: Stent, vascular, intracranial
Intended purpose
The Pipeline Flex Embolization Device (PED) is intended for endovascular embolization of cerebral aneurysms.
Functional description
The Pipeline Flex 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 guide-wire approximately 200 cm long and compressed inside an introducer sheath.