Device Dossier

Indigo System Lightning - Embolectomy/thrombectomy suction catheter

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

Intended purpose

INDIGO Aspiration Catheters As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. INDIGO Aspiration Tubing As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.

Functional description

The Indigo System Lightning Kits consist of Indigo Aspiration Catheters packaged together with Lightning Aspiration Tubing. Aspiration Catheters are vascular catheters that serve a conduit to aspirate thrombus from an occluded vessel. Lightning Aspiration Tubing utilizes software which monitors two pressure sensors along the length of the tubing to determine whether or not the tubing vale is open or shut.

TGA Public Summary