Endologix has announced the presentation of positive clinical data for the Nellix EndoVascular Aneurysm Sealing (EVAS) system at the 38th Annual Charing Cross Symposium (26–29 April, London, UK). This includes updated data from the Nellix EVAS-FORWARD–Global Registry and a data presentation from Jean-Paul de Vries (Nieuwegein, Netherlands) entitled “Endovascular sealing of common iliac artery aneurysms—multicentre experience”. The Nellix EVAS system is approved for investigational use only in the USA.
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
- Freedom from endoleaks of 98%
- Secondary interventions in 6.5% of patients treated on-label
- 98% aneurysm-related and 93% overall survival.
The study results presented by de Vries included 72 patients with abdominal aortic aneurysm and iliac artery aneurysms treated with the Nellix EVAS system. Forty per cent of patients had iliac artery aneurysm diameters beyond indications for use in traditional EVAR devices. The patients were enrolled at 9 centres 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
- Secondary intervention rate of 5.6%.
de Vries commented, “Up to one-third of abdominal aortic aneurysm patients also have some form of iliac artery aneurysm, which can involve more complex and expensive procedures including embolisation and iliac branch devices. The results from our study demonstrate that the Nellix device can safely and effectively treat these patients with a straightforward, faster and cost-effective procedure.”
Endologix says that the Nellix EVAS system is a new generation of abdominal aortic aneurysm therapy designed to seal the entire aneurysm sac. It is the first and only EVAS product and was developed to reduce all types of endoleaks and improve long-term patient outcomes. The recently announced next-generation Nellix EVAS system incorporates design improvements to enhance ease of use and offers physicians more sizes to treat more abdominal aortic aneurysm patients. Nellix is an investigational device in the USA.