Device Dossier
Optima Coil System - Neurovascular embolization coil
Device Dossier for Optima Coil System - Neurovascular embolization coil (Neurovascular embolization coil, Class III, sponsor Balt). ARTG record, intended…
- GMDN category: Neurovascular embolization coil
Intended purpose
The Optima Coil System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular vessels.
Functional description
The platinum alloy radiopaque coil is attached to the delivery system at the distal end. The delivery system is composed of an introducer and pusher assembly. The pusher controls the deployment of the coil through a microcatheter until detachment is desired. Following placement, the embolization coils are designed to form a mechanical obstruction that effects total vascular occlusion.