AngioDynamics (NASDAQ:ANGO) has secured a label expansion for its AlphaVac F1885 System from the U.S. Food and Drug Administration (FDA).
The expanded FDA indication allows for the utilization of the AlphaVac F1885 System for the treatment of pulmonary embolism (PE), which affects around 900,000 people in the U.S. every year and is the third leading cause of cardiovascular mortality in the nation.
The system was tested for safety and efficacy in a single-arm APEX-AV study, which enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the U.S. The study met its primary endpoints and showed a meaningful, favorable reduction in clot burden.
The approval broadens the applicability of the AlphaVac in the non-surgical removal of thrombi or emboli from the venous vasculature.
Shares of the med-tech firm jumped over 9% premarket in response to the approval and Q3 earnings.