Positive two-year clinical data from Endologix’ Nellix EVAS FORWARD investigative device exemption trial have been presented at the Society of Vascular Surgery (SVS; 31 May–3 June) 2017 annual meeting. The trial prospectively enrolled patients with abdominal aortic aneurysms (AAA) who were treated with the Nellix endovascular aneurysm sealing system.
The study’s principal investigator, Jeffrey Carpenter, professor and chairman of surgery for Cooper Medical School and chief of Surgery for Cooper Health System (both Camden, USA), presented the results.
Key findings from the data included:
- Freedom from all endoleaks (94%), rupture (97%), all-cause mortality (97%), and cardiovascular mortality (99%), among all patients.
- Highest freedom of type II endoleaks, of 97%, ever reported at two years, among all patients.
- 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.
Carpenter said, “The overall two-year results for EVAS with Nellix are very encouraging. In particular, the refined IFU appears to offer excellent patient outcomes, and we look forward to validating these results in the upcoming prospective confirmatory study.”