AngioDynamics Files for 510(k) Clearance for Mechanical Thrombectomy System
AngioDynamics has submitted a 510(k) clearance application to the FDA for its AlphaVac System, a multi-purpose mechanical aspiration thrombectomy device.
The company hopes to earn the FDA’s clearance for removing undesirable material in veins and arteries, including thrombus, embolus and vegetation found in the venous system and peripheral vasculature.
The device includes a new mechanical aspiration handle and a self-expanding funnel tip. It is designed to offer precise control in the removal of clots while minimizing blood loss. The company said it anticipates receiving clearance in the second half of 2021.