Device Dossier

SOFIA Guiding Catheter - Embolectomy/thrombectomy suction catheter

Device Dossier for SOFIA Guiding 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 support and facilitate the use of additional neuro devices and to remove emboli and thrombi from selected blood vessels. It is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal segment is steam-shapeable to facilitate vessel selection. It is usually positioned in more proximal anatomy. It has a hydrophilic coating for navigation and the radiopaque marker is located at the distal end for visualisation.

TGA Public Summary