Aventus Thrombectomy System

The Aventus Thrombectomy System is a catheter-based manual aspiration device designed for minimally invasive removal of blood clots (emboli and thrombi) from blood vessels, particularly in the peripheral vasculature and pulmonary arteries. It also enables injection, infusion, and aspiration of contrast media and other fluids. The system comprises an aspiration catheter with an atraumatic tip and embedded sensors, plus a 60-cc manual syringe and clot canister.

Both the subject and predicate devices are single-patient-use, large-bore aspiration catheters utilizing a 60-cc manual syringe for aspiration. They share metallic (stainless steel) reinforced polymeric shafts with variable stiffness, radiopaque distal-tip markings for fluoroscopy, disposable powered electronics with embedded software, and stopcocks for fluid flow direction. The key modification is the addition of a hydrophilic coating to the outer catheter shaft of the subject device.

ISO 10993-1:2018 (biocompatibility), ISO 14937:2009 (sterilization validation), USP <85> and AAMI ST72 (bacterial endotoxin testing), IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 62366-1 (electrical safety and EMC), plus FDA guidance on animal studies and software content for medical devices.

The Aventus Thrombectomy System is substantially equivalent to its predicate device (K251189) because both share identical intended uses, indications for use, and core technological characteristics as single-patient-use aspiration catheters with manual syringe actuation. Performance testing—including biocompatibility, sterilization, bench testing for coating integrity, animal studies, and clinical data from the AVENTUS trial—demonstrates safety and effectiveness equivalent to the predicate, with the minor modification of hydrophilic coating not affecting the fundamental function or safety profile.