FORWARD IDE trial shows benefits of Nellix EVAS System in reduced leakage and mortality in patients with abdominal aortic aneurysms- Endologix

Endologix announced the presentation of two-year clinical data from the Company's Nellix EVAS FORWARD IDE trial that prospectively enrolled patients with abdominal aortic aneurysms who were treated with the Nellix Endovascular Aneurysm Sealing System (Nellix EVAS System). Key highlights from the two-year data included freedom from all endoleaks (94%), rupture (97%), all-cause mortality (97%), and cardiovascular mortality (99%), among all patients.

It also showed the highest freedom of type II endoleaks, of 97%, ever reported at two years, among all patients. Finally, when applying the refined IFUs for Nellix, patients at the two-year follow-up demonstrated a highly encouraging 96% freedom from Type Ia endoleak, migration, and sac growth. The data were presented at the Society of Vascular Surgery 2017 Vascular Annual Meeting.

Comment: The Nellix EVAS System was CE mark approved in the EU in 2012 but is approved for investigational use only in the US.