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The MegaVac Mechanical Thrombectomy System is indicated for: - The non-surgical removal of emboli and thrombi from blood vessels. - The non-surgical removal of thrombi from synthetic grafts. - Use in temporary blood vessel/graft occlusion. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft - Catheter placement over a guidewire

The MegaVac Mechanical Thrombectomy System consists of two single-use devices, the MegaVac Catheter with SafeSeal technology and a ThromboWire clot retractor, for intravascular mechanical thrombectomy, occlusion, aspiration and embolectomy. The MegaVac Catheter with SafeSeal technology utilizes a silicone coated nitinol braided funnel that expands to occlude antegrade blood flow proximal to the target work zone creating a static environment in which to perform the intervention, while also centering and securing the catheter tip position within the vessel. The MegaVac catheter's large-mouth funnel and inner diameter allows for strong aspiration while easily being able to pass the ThromboWire and other lesion disruptive or therapeutic devices through it. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle can serve to gather and pull matter towards and through the MegaVac catheter during aspiration.