Device Dossier

SOFIA Plus Catheter - Embolectomy/thrombectomy suction catheter

Device Dossier for SOFIA Plus Catheter - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III, sponsor Life…

Intended purpose

The SOFIA™ Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA™ Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The SOFIA™ Catheter is not intended for use in coronary arteries. Moreover, the SOFIA™ Catheter is intended for use in removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neuro vasculatures

Functional description

The SOFIA™ Catheter is used to remove emboli and thrombi from selected blood vessels having longer working lengths (>115cm). It is non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal segment is steam-shapeable to facilitate vessel selection and also has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.

TGA Public Summary