Clinical Outcomes

Summary

The AneuRx^® Abdominal Stent Graft System represents the largest clinical cohort of any approved endograft, with over 600 patients and 5 years of follow-up. The clinical data demonstrates that the AneuRx stent graft is safe and effective as evidenced by freedom from aneurysm rupture in 97% of patients, freedom from conversion to surgical repair in 92% of patients, and freedom from aneurysm-related death in 96% of patients at 5 years.

In the AneuRx-Post-Market Surveillance Registry, which provides additional real-world usage data in support of the AneuRx stent graft commercial performance, patients experienced freedom from aneurysm rupture of 99% at 3 years and freedom from surgical conversion of 96% at 3 years. These results compared to those from the original clinical trial may be reflective of the evolution in the stent graft technology (currently in ninth generation AneuRx stent graft technology), implantation techniques, and patient selection criteria.

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IMPORTANT

The AneuRx AAAdvantage Abdominal Stent Graft System has been shown to be safe and effective through over 5 years of clinical data. Longer term data is required to examine the rate of adverse events including surgical conversion, aneurysm-related death, migration and endoleak beyond this time frame.