Aventus Thrombectomy System

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed to remove blood clots (emboli and thrombi) from peripheral blood vessels and to inject, infuse, or aspirate contrast media and other fluids. The system comprises an aspiration catheter with embedded sensors, a 60-cc manual syringe, and a clot canister, and is provided sterile for single use only.

The subject device (model IM-2200) differs from the predicate (model IM-2001) in three ways: simplification of lumen construction from three to one with re-routed ports and addition of a Navigation Port valve; repositioning of electrical wires within the catheter wall; and removal of distal infusion holes. Both share identical technological foundations: single-patient-use large-bore aspiration catheters using a 60-cc manual syringe, stainless-steel-reinforced polymeric shafts with variable stiffness, radiopaque distal markings, embedded electronics, and stopcocks for flow control.

ISO 10993-1:2018 (biocompatibility), ISO 14937:2009 (sterilization), IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 62366-1 (electrical safety and EMC), USP <85> and AAMI ST72 (bacterial endotoxin testing), 21 CFR Part 58 (GLP animal studies).

The subject device has identical intended use and indications as the predicate device (thrombi/emboli removal from peripheral vasculature). Although the IM-2200 model incorporates three design modifications to the catheter construction, these changes are minor refinements that maintain the fundamental functional characteristics and do not alter the device's mechanism of action or clinical purpose. Performance testing—including bench design verification, biocompatibility, sterilization, electrical safety, and GLP animal studies—all leveraged or built upon equivalent testing from the predicate device and demonstrated that the subject device meets all performance requirements and safety endpoints.