Device Dossier

Indigo System Separator 4 - Embolectomy/thrombectomy suction catheter

Device Dossier for Indigo System Separator 4 - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III, sponsor…

Intended purpose

As part of the INDIGO Aspiration System, the Separator 4 is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

Functional description

The Indigo System Separator 4 may be used to clear the lumen of the INDIGO CAT RX Aspiration Catheter should it become blocked with thrombus. INDIGO System Separator 4 may be deployed from the INDIGO CAT RX Aspiration Catheter to assist with thrombus removal. The INDIGO System Separator 4 is advanced and retracted through the INDIGO CAT RX Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO CAT RX Aspiration Catheter tip.

TGA Public Summary