AngioDynamics Receives FDA Breakthrough Device Designation for the AngioVac System for the Non-Surgical Removal of Right Heart Vegetation
The FDA Breakthrough Device designation is designed to help patients gain timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved or cleared alternatives exist.
- The FDA Breakthrough Device designation is designed to help patients gain timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved or cleared alternatives exist.
- 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 (IVC), Superior Vena Cava (SVC) and Right Heart.
- Under the Breakthrough Device designation, AngioDynamics will engage with the FDA to achieve this new expanded indication for the non-surgical removal of vegetation from the right heart.