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AngioDynamics Receives FDA Breakthrough Device Designation for the AngioVac System for the Non-Surgical Removal of Right Heart Vegetation
Pivotal Milestone Accelerates Pathway to Specific Indication LATHAM, N.Y.--(BUSINESS WIRE)-- AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative
About this update from Angiodynamics, Inc.
[{"type":"text","content":"\nPivotal Milestone Accelerates Pathway to Specific Indication\n\n\n LATHAM, N.Y.--(BUSINESS WIRE)--\nAngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s AngioVac System for the proposed indications for use to include the non-surgical removal of vegetation from the right heart.\n\n\nThe 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.\n\n\n“The FDA’s recognition of the AngioVac System and its potential to provide a novel and innovative treatment pathway for the non-surgical removal of vegetation from the right heart represents a significant step in our journey to advance patient care,” said Jim Clemmer, AngioDynamics’ President and Chief Executive Officer. “The support of our physician partners continues to lead us in the development, study and application of this innovative technology to treat and manage critical medical conditions for a patient population with an unmet need.”\n\n\nThe 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 six 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 (IVC), Superior Vena Cava (SVC) and Right Heart.\n\n\nUnder 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. 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 d...