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The Expanse ICE Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The Expanse ICE Aspiration System is a peripheral thrombectomy system consisting of several components: - ICE Aspiration Catheter - - ICE Aspiration Sheath - - -Vacuum Fitting - -High Flow Stopcock Connector - -Y-Connector with Hemostatic Valve - Hand Actuator Clip - The ICE Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. It is a single use, over-the-wire, catheterbased system with the ability to infuse fluid. The ICE Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip. The ICE Aspiration System is introduced to the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg). Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. No saline is injected into the patient during aspiration. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.