For United States:
The Nellix EndoVascular Aneurysm Sealing System is CE marked. Prior to use, refer to the “Instructions for Use” for complete and specific indications, contraindications, all warnings and precaution. Rx Only. This product has not been approved for clinical investigation or for marketing in the United States.
Nellix is an investigational EndoVascular Aneurysm Sealing (EVAS) system designed for the treatment of infrarenal abdominal aortic aneurysm (AAA). EVAS is the next generation AAA therapy intended to treat more anatomies than currently approved endovascular stent graft devices, and is the only technology whose operating principle is centered around sealing the aneurysm sac.
Nellix was designed to address unmet clinical needs, and potentially reduce the need for secondary interventions following endovascular AAA repair. In initial clinical trial experience involving 34 patients outside of the United States (Krievins DK, et al., EVAR using the Nellix Sac-anchoring Endoprosthesis: Treatment of Favourable and Adverse Anatomy, EUR J Vasc Endovasc Surg (2011), doi: 10.1016/j.ejvs.2011.03.007), 100% implant success was observed. To two year follow-up, no aneurysm rupture, conversion to open surgery or stent graft migration has been observed. One secondary procedure for distal Type I endoleak has been performed (2.9% of patients). Physician feedback has been positive, particularly as it relates to ease of use and versatility to treat both standard and more challenging aneurysm anatomies.