Endologix today announced it received FDA approval for a pre-market approval supplement relating to its AFX2 system.
The expanded approval includes an updated warning and the most contemporary clinical information in the labeling for the AFX2 system. Clinical data was added to the instructions for use (IFU) to include:
– Final results from the five-year Leopard randomized controlled trial;
– Results from the recently published, independently performed, VQI-Vision analysis on AAA endographs.
Both studies showed rates for rupture and re-intervention are comparable between AFX/AFX2 device cohort and end-vascular aneurysm repair comparator devices. 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.
Endologix’s AFX2 is a bifurcated endograft system with a 7Fr contralateral introducer and 17F ipsilateral introducer. It has an integrated contralateral wire that obviates 0.014 wire exchange. Endologix designed the AFX2 system with unique sealing technology that preserves native bifurcation to provide durable outcomes and personalized repair for AAA patients.
AFX2 received CE mark approval in August and won FDA clearance in 2015.
