AngioDynamics AngioVac Receives Breakthrough Device Designation for Nonsurgical Removal of Right Heart Vegetation

August 15, 2023—AngioDynamics, Inc. announced that the FDA has granted Breakthrough Device designation for the company’s AngioVac system for a proposed indication for use to include the nonsurgical removal of vegetation from the right heart.

According to the company, the AngioVac system is an on-circuit aspiration system that uses a venous drainage cannula to remove thrombi or emboli during extracorporeal bypass for up to 6 hours. The system allows for the removal of thrombus and embolic material while minimizing blood loss via a recirculation of blood through the AngioVac extracorporeal (venovenous) bypass circuit. Target vessels for the thrombus/embolus extraction include but are not limited to the iliofemoral vein, inferior vena cava, superior vena cava, and right heart.

The company advised that under the Breakthrough Device designation, it will engage with the FDA to achieve this new expanded indication for the nonsurgical removal of vegetation from the right heart.

The accelerated pathway expedites assessment and review processes of the AngioVac system and allows for more interactive and timely communication with the FDA, efficient and flexible clinical study design, FDA review team support, agency senior management engagement, and priority review, stated the company.

Currently, the AngioVac C20 and C180 are indicated for use as venous drainage cannulas and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours. The AngioVac F18⁸⁵ is indicated as a venous drainage cannula for the non-surgical removal of thrombi or emboli during extracorporeal bypass for up to 6 hours. The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to 6 hours, advised AngioDynamics.