AngioDynamics Secures FDA 510(k) Clearance for AlphaVac F1885 System in Pulmonary Embolism Treatment

Friday, April 05, 2024

AngioDynamics recently announced that the AlphaVac F1885 System has received clearance from the United States Food and Drug Administration (FDA) for the treatment of pulmonary embolism (PE). This clearance is a notable achievement in medical technology as PE affects a considerable number of individuals in the United States each year and ranks as a leading cause of cardiovascular mortality.

The FDA's approval expands the application of the AlphaVac F1885 System beyond its previous use, allowing for the non-surgical removal of thrombi or emboli from the venous vasculature, specifically in cases of PE. This broader indication offers healthcare professionals additional options for managing PE, potentially leading to benefits such as reducing thrombus burden and improving right ventricular function.

AngioDynamics' commitment to prioritizing both physician-centric design and patient outcomes is evident in this development, underscoring the company's dedication to advancing patient care and safety.

Additionally, the completion of patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study provides valuable data on the effectiveness and safety of the AlphaVac F1885 System in treating PE. This study's primary endpoints focused on evaluating reductions in RV/LV ratio and assessing major adverse events, contributing valuable insights to support the device's efficacy.

Overall, the FDA clearance of the AlphaVac F1885 System represents a significant milestone in PE treatment, offering healthcare providers a valuable tool to address this critical condition and potentially enhance patient outcomes.






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