Endologix recently announced that it has received US Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2 system.
According to a company press release, Endologix received approval to include an updated warning and the most contemporary clinical information in the labelling for the AFX2 system. Clinical data added to the instructions for use (IFU) includes: final results from the five-year LEOPARD randomised controlled trial, and results from the recently published, independently performed, VQI-VISION analysis on abdominal aortic aneurysm (AAA) endografts.
Endologix notes that in both reported studies, out to three years, the rates shown for rupture and reintervention are comparable between the AFX/AFX2 device cohort and endovascular aneurysm repair (EVAR) comparator devices. Additionally, results from the LEOPARD study demonstrated no significant difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and Type I and Type III endoleaks between the AFX/AFX2 device cohort and the EVAR comparator devices.