Device Dossier

Apollo Onyx Delivery Microcatheter - Catheter, intravascular, guiding

Device Dossier for Apollo Onyx Delivery Microcatheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor…

Intended purpose

The Apollo microcatheter is intended to access the neurovasculature for the controlled selective infusion of clinician-specified therapeutics including embolisation materials and diagnostic agents such as contrast media.

Functional description

The Apollo Onyx Delivery Catheter is a single-lumen catheter designed to facilitate catheter retrieval in the event it becomes entrapped within the vasculature. The catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft. The distal section of the catheter incorporates a mechanical detachment zone that allows detachment of the tip when the force required to extract the catheter exceeds the force to detach the tip.

TGA Public Summary