AngioDynamics receives FDA breakthrough device designation for AngioVac system

AngioDynamics announced that the U.S. Food and Drug Administration 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. 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’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.”