Clinical results presented for Nellix EndoVascular Aneurysm Sealing System in abdominal aortic aneurysms- Endologix

Endologix announced the presentation of positive clinical data for the Nellix EndoVascular Aneurysm Sealing System, including updated data from the Nellix EVAS-FORWARD – Global Registry. Global Registry data includes a total of 300 patients with a mean follow-up of 20 months. The key highlights from the Global Registry data included 37% of patients treated had complex abdominal aortic aneurysms, they had freedom from endoleaks of 98%. In addition, secondary interventions in 6.5% of patients treated on-label and 98% aneurysm-related and 93% overall survival.

The study results included 72 patients with AAA and iliac artery aneurysms treated with the Nellix EVAS System. Forty percent of patients had iliac artery aneurysm diameters beyond indications for use in traditional EVAR devices. The patients were enrolled at 9 centers and had a mean follow-up of 13 months. The highlights from the data include: 100% technical success, mean common iliac artery diameters of 35mm (right CIA) and 29mm (left CIA), 108 minute average procedure time and a secondary intervention rate of 5.6%. Data were presented at the 38th Annual Charing Cross Symposium.

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