Development and validation of a novel endovascular thrombectomy device to treat deep vein thrombosis: a preclinical study in a swine model.

Abstract

This study evaluated the safety and efficacy of a novel endovascular thrombectomy device in a swine model of deep vein thrombosis (DVT). The device has an over-the-wire configuration, a manually expandable catching basket, a funnel sheath with a covered stent to minimize the risk of microembolization, and an integrated delivery system. DVT was induced by occluding the right iliac vein with a balloon catheter and injecting thrombin. The novel device was inserted into the inferior vena cava through the right jugular vein access. The device effectively removed the thrombus, restoring venous patency without residual thrombus, vessel injury, or complications. These findings suggest the potential advantages of the novel device over predicate devices. Further clinical evaluation is needed to establish the efficacy of this device in human patients with DVT.