Data Presented for Endologix's Nellix Endovascular Aneursym Sealing System

April 27, 2016—Endologix, Inc. announced that positive clinical data for the Nellix endovascular aneurysm sealing (EVAS) system were presented at the Charing Cross Symposium in London, United Kingdom.

In the presentation at Charing Cross titled, “Endovascular Sealing of Common Iliac Artery Aneurysms—Multicenter Experience,” Jean-Paul De Vries, MD, provided updated data from the Nellix EVAS-FORWARD–Global Registry. Dr. De Vries is Head of the Department of Vascular Surgery at St. Antonius Hospital in Nieuwegein, the Netherlands.

The global registry was composed of 300 patients with a mean follow-up of 20 months. Thirty-seven percent of patients had complex abdominal aortic aneurysms (AAA). Treatment results included a freedom from endoleaks of 98%, secondary interventions in 6.5% of patients treated on-label, 98% aneurysm-related survival, and 93% overall survival.

The data presented by Dr. De Vries included 72 patients with AAA and iliac artery aneurysms treated with the Nellix EVAS system. Patients were enrolled at nine centers and had a mean follow-up of 13 months. Forty percent of patients had iliac artery aneurysm diameters that were beyond indications for use in traditional endovascular repair devices.

Dr. De Vries reported that there was 100% technical success, mean common iliac artery (CIA) diameters of 35 mm (right CIA) and 29 mm (left CIA), 108-minute average procedure time, and a secondary intervention rate of 5.6%. He commented, “Up to one-third of AAA patients also have some form of iliac artery aneurysm, which can involve more complex and expensive procedures including embolization 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.”

According to the company, the Nellix EVAS system is designed to seal the entire AAA sac. It was developed to reduce all types of endoleaks and improve long-term patient outcomes. 

The next-generation Nellix EVAS System, which recently received European CE Mark approval, incorporates design improvements to enhance ease of use and offers physicians more sizes to treat more patients with AAA. Nellix is an investigational device in the United States, advised Endologix.