Device Dossier

Axium™ Prime Bare Platinum Extra Soft Coils - Neurovascular embolization coil

Device Dossier for Axium™ Prime Bare Platinum Extra Soft Coils - Neurovascular embolization coil (Neurovascular embolization coil, Class III, sponsor…

Intended purpose

The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Functional description

The Axium™ Prime Detachable Coil consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Axium™ I.D. (Instant Detacher) which when activated in the Neurovasculature detaches the coil from the delivery pusher tip. The AXIUM™ I.D. (Instant Detacher) is sold separately.

TGA Public Summary