Device Dossier

Navien A+ Intracranial catheter - Catheter, intravascular, guiding

Device Dossier for Navien A+ Intracranial catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Medtronic).…

Intended purpose

The Navien A+ Intracranial support Catheter is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary, and neuro vasculature. The Navien A+ Intracranial Support Catheter is also indicated for the removal/aspiration of fresh, soft emboli and thrombi from selected blood vessels in the arterial system, including neurovasculature.

Functional description

The Navien A+ Intracranial Support Catheter is a single lumen, flexible, variable stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Navien A+ Intracranial Support Catheter is visible under fluoroscopy.

TGA Public Summary