Device Dossier

Indigo Separators (Nitinol) - Embolectomy/thrombectomy suction catheter

Device Dossier for Indigo Separators (Nitinol) - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III, sponsor…

Intended purpose

As part of the INDIGO Aspiration System, the INDIGO Nitinol separators are intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli.

Functional description

The INDIGO Separator (Nitinol core wire) may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip.

TGA Public Summary