AngioDynamics (Nasdaq:ANGO) announced that it received FDA breakthrough device designation for its AngioVac system.
The breakthrough nod includes proposed indications for the use of AngioVac in the non-surgical removal of vegetation from the right heart.
AngioVac, an on-circuit aspiration system, uses a venous drainage cannula to remove thrombi or emboli during extracorporeal bypass. It achieves this for up to six hours, allowing for removal while minimizing blood loss. The system recirculates blood through the AngioVac extracorporeal (venovenous) bypass circuit.
Target vessels include — but aren’t limited to — the iliofemoral vein, inferior vena cava, superior vena cava and right heart.
With breakthrough designation, AngioDynamics plans to engage with the FDA to achieve its new expanded indication for the right heart. The accelerated pathway expedites assessment and review processes for the system with more interactive and timely communication with the agency. it also enables flexible clinical study design, FDA review team support and priority review.
“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 CEO. “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.”
