Device Dossier

SOFIA Flow 88 Catheter - Embolectomy/thrombectomy suction catheter

Device Dossier for SOFIA Flow 88 Catheter - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III, sponsor Life…

Intended purpose

The SOFIA Flow 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA Flow 88 Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The SOFIA Flow 88 Catheter is not intended for use in coronary arteries. Moreover, the SOFIA Flow 88 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 Flow 88 Catheter is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal segment is designed to facilitate vessel selection with 60 cm of distal-shaft hydrophilic coating for navigation through the vasculatures. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.

TGA Public Summary