Nellix EndoVascular Aneurysm Sealing System: Device description, technique of implantation, and literature review

Clinical outcome reports document that from 30% to 60% of endovascular aneurysm repair procedures are performed outside of US Food and Drug Administration−approved Instruction for Use, or “off label.” Endovascular aneurysm repair performed outside of Instruction for Use has a significantly higher rate of device failure, potentially requiring device reintervention and even planned or emergent explant. The Nellix device has the potential to reduce the rate of aneurysm device failure through its novel design. The objective of this article was to introduce the Nellix EndoVascular Aneurysm Sealing System and indications for use and describe the technique of implantation. We describe various modes of endovascular aneurysm repair failure and how the Nellix system can reduce these unplanned adverse outcomes. Additional clinical applications and theoretical shortcomings of endovascular aneurysm sealing devices are detailed.