Device Dossier
POD System - Embolization implant kit
Device Dossier for POD System - Embolization implant kit (Neurovascular embolization coil, Class III, sponsor Penumbra Neuro). ARTG record, intended…
- GMDN category: Neurovascular embolization coil
Intended purpose
For POD Coils with nominal sizes ≤ 6mm: POD System is indicated for the embolization of: • Intracranial aneurysms. • Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. • Arterial and venous embolizations in the peripheral vasculature. For POD Coils with nominal sizes > 6mm: POD System is indicated for the arterial and venous embolizations in the peripheral vasculature.
Functional description
The POD System functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of bare-platinum coils to achieve occlusion in an equivalent fashion to existing bare-platinum embolization coils, including the Penumbra Coil System. The POD System consists of three components: a Coil Implant, attached to a Detachment Pusher, and a Detachment Handle.