Conclusion
The Nellix EVAS system had been proven to fulfill the objective of eliminating type II endoleaks and as presented at the Charing Cross International Symposium in April 2018, seems to have lower mid-term mortality rates than conventional EVAR systems. However, our study showed a high percentage of stent graft angulation, graft migration, limb separation and ultimately type Ia endoleak at mid-term follow-up, likely due to insufficient proximal anchoring of the device. It is important therefore to specifically look for these device-specific complications during follow-up for patients who have received these endografts. An improved proximal stent fixation could possibly help to improve the mid-term success rate of EVAS.
These device issues have been recognized by Endologix and they have released a field safety notice at the beginning of 2019, effectively ceasing sales due to the aforementioned adverse events.