Aventus Thrombectomy System

The Aventus Thrombectomy System is a catheter-based manual aspiration device for minimally invasive removal of emboli and thrombi from blood vessels. It is intended for use in peripheral vasculature and pulmonary embolism treatment, and can also inject, infuse, or aspirate contrast media and other fluids into or from blood vessels.

Both the subject device and predicate (Inari FlowTriever) are single-patient-use, large-bore aspiration catheters using a 60-cc manual syringe as the aspiration source. Both incorporate disposable powered electronics and embedded software, utilize stainless steel-reinforced polymeric shafts with variable stiffness, include radiopaque distal tip markings for fluoroscopic visualization, and use stopcocks to direct fluid flow. Neither device includes coating or surface materials.

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

The Aventus system shares identical indications for use with the predicate device (thrombi/emboli removal and fluid injection/aspiration in peripheral vasculature and pulmonary embolism). The technological characteristics are substantially identical: both use the same 60-cc manual syringe aspiration mechanism, metallic-reinforced polymeric shafts, and embedded electronics. Performance testing leveraged from the reference device (identical Aventus K240117) demonstrated equivalent biocompatibility, sterilization, and bench performance. Clinical trial data (AVENTUS trial, N=120) showed zero device-related major adverse events and significant RV/LV ratio improvement, meeting predefined safety and efficacy endpoints equivalent to predicate performance.