Device Dossier

SPI (Platinum Free Spirals without fibers) - Neurovascular embolization coil

Device Dossier for SPI (Platinum Free Spirals without fibers) - Neurovascular embolization coil (Neurovascular embolization coil, Class III, sponsor…

Intended purpose

Designed for intravascular use for venous or arterial embolisations. They permit the treatment of arteriovascular, fistular arterio-venous malformations, varicoceles, angiomas or vascular lesions and aneurysms.

Functional description

A platinum spring or coil rolled into a spiral intended to promote thrombogenicity. The spring is put onto a straightening mandrel to allow introduction into a catheter, the mandrel is withdrawn and the coil is advanced, positioned and released using either, a) guidewire and angiography or b) a syringe and sterile saline or contrast media and fluoroscopy.

TGA Public Summary