Device Dossier

Indigo System - Lightning Bolt - Embolectomy/thrombectomy suction catheter

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

Intended purpose

The Indigo Aspiration Catheters are intended 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. the Indigo Bolt Aspiration Tubing is intended to connect the Indigo Aspiration Catheters to the Aspiration Pump.

Functional description

The Indigo System Lightning Bolt consists of an Aspiration Catheter and the Lightning Bolt Aspiration Tubing designed to remove thrombus from the vasculature using aspiration. The Aspiration Catheter targets aspiration from the pump onto the thrombus. Lightning Bolt Aspiration Tubing is designed to serve as a conduit between the Aspiration Pump and the Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. TraX may be used with its size-fit Aspiration Catheter.

TGA Public Summary