Device Dossier

Hydrocoil Embolic System - Neurovascular embolization coil

Device Dossier for Hydrocoil Embolic System - Neurovascular embolization coil (Neurovascular embolization coil, Class III, sponsor Life Healthcare). ARTG…

Intended purpose

For the 1) endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as anteriovenous malformations and anteriovenous fistulae. 2) vascular occlusion of blood vessels within the neurovascular system to an aneurysm or other vascular malformation 3) for arterial and venous embolizations in the peripheral vasculature.

Functional description

An implantable coil attached to a V-Trak delivery pusher. They are platinum coils augmented with a hydrophilic polymer. Each coil type must be delivered only through a wire-reinforced microcatheter with the minimum inner diameter specified.

TGA Public Summary