Device Dossier

SOFIA Distal Access Catheter - Embolectomy/thrombectomy suction catheter

Device Dossier for SOFIA Distal Access Catheter - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III,…

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 and to support and facilitate the use of additional neuro devices. 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 and usually positioned in distal anatomy. It has a hydrophilic coating for navigation and the radiopaque marker is located at the distal end of the catheter for visualization.

TGA Public Summary