AngioDynamics has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its AngioVac System for the non-surgical removal of right heart vegetation.
Utilising a venous drainage cannula, the on-circuit aspiration system eliminates thrombi or emboli during extracorporeal bypass for up to six hours.
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It enables the removal of thrombus and embolic material while reducing blood loss through the recirculation of blood via the AngioVac extracorporeal (venovenous) bypass circuit.
The thrombus/embolus extraction procedure focuses on various vessels including, but not limited to, the iliofemoral vein, inferior vena cava, superior vena cava and right heart.
AngioDynamics president and CEO Jim Clemmer said: “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.
“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.”
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By GlobalDataIn June of this year, Merit Medical Systems completed the acquisition of a dialysis catheter product portfolio and the BioSentry Tract Sealant System Biopsy product from AngioDynamics for a cash consideration of $100m.
AngioDynamics aims to use the proceeds from the transaction to clear its existing debt and make strategic investments in growth and profitability.
