AngioDynamics, Inc. announced that the United States Food and Drug Administration (FDA) has cleared the AlphaVac F1885 System for the treatment of pulmonary embolism (PE), enhancing its utility in critical medical scenarios such as PE. PE affects around 900,000 people in the United States every year and is the third leading cause of cardiovascular mortality in the nation.1,2 Patients with sub-massive or intermediate-risk PE account for 35% to 55% of hospitalized patients with PE and have a mortality rate of 3% to 14%. The expanded FDA indication allows for the utilization of the AlphaVac F1885 System for the treatment of PE, which broadens the applicability of the AlphaVac F1885 System in the non-surgical removal of thrombi or emboli from the venous vasculature.

The indication expands treatment options for patients with PE, reducing thrombus burden and improving right ventricular function. The primary efficacy endpoint of the APEX-AV Study was the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint was the rate of Major Adverse Events (MAEs), including events such as major bleeding and serious device-related clinical deterioration, pulmonary vascular injury, and cardiac injury, within the first 48 hours.

Patients were followed for 30 days post-index procedure.