Sam Brusco, Associate Editor08.15.23
AngioDynamics has earned Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its AngioVac system, for the proposed indication to include non-surgical removal of vegetation from the right heart.
AngioVac is an on-circuit aspiration system with a venous drainage cannula to remove thrombi or emboli during extracorporeal bypass for up to six hours. The system helps to remove thrombus and embolic material while minimizing blood loss via blood recirculation through the AngioVac extracorporeal bypass circuit.
Target vessels for thrombus/embolus extraction include, the iliofemoral vein, inferior vena cava (IVC), superior vena cava (SVC), and right heart.
“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,” Jim Clemmer, AngioDynamics’ president and CEO told the press. “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.”
The company sold its portfolio of dialysis catheters and BioSentry biopsy tract sealant systems to Merit Medical Systems for $100 million in June.
AngioVac is an on-circuit aspiration system with a venous drainage cannula to remove thrombi or emboli during extracorporeal bypass for up to six hours. The system helps to remove thrombus and embolic material while minimizing blood loss via blood recirculation through the AngioVac extracorporeal bypass circuit.
Target vessels for thrombus/embolus extraction include, the iliofemoral vein, inferior vena cava (IVC), superior vena cava (SVC), and right heart.
“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,” Jim Clemmer, AngioDynamics’ president and CEO told the press. “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.”
The company sold its portfolio of dialysis catheters and BioSentry biopsy tract sealant systems to Merit Medical Systems for $100 million in June.