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…

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.

TGA Public Summary