EVAS FORWARD—Global Registry Supports Endologix's Nellix Device

April 29, 2015—Endologix, Inc. announced that updated clinical data from the company’s EVAS FORWARD—Global Registry were presented by Professor Matt Thompson, MD, at the Charing Cross Symposium being held April 28 to May 1 in London, United Kingdom. The EVAS FORWARD—Global Registry prospectively enrolled patients with abdominal aortic aneurysms (AAAs) who were treated with the company’s Nellix endovascular aneurysm sealing (EVAS) system. 

Endologix stated that the Nellix EVAS system is designed to seal the entire aneurysm sac and was developed to mitigate all types of endoleaks and improve stability and long-term patient outcomes. The Nellix EVAS system has obtained European CE Mark approval. In the United States, the system is approved for investigational use only.

Prof. Thompson, who is with St. Georges Vascular Institute in London, is one of the Principal Investigators of the registry. In Endologix’ press release, Prof. Thompson commented, “Results from the Nellix EVAS FORWARD—Global Registry continue to be very promising, including low rates of endoleaks, reinterventions, and mortality. The early data is impressive, especially considering the limited experience that many investigators had with the EVAS technology and the broad range of AAA anatomies treated in the study.”

According to Endologix, clinical investigators enrolled 300 patients treated with the Nellix EVAS system at centers in Europe and New Zealand from October 2013 to September 2014. Patients enrolled in the EVAS FORWARD—Global Registry will be followed for 5 years, with primary endpoints evaluating safety and effectiveness of the Nellix EVAS system at 12 months postprocedure. The study includes core lab assessment of CT scans and independent physician adjudication of outcomes.

The global registry data includes a total of 300 patients with a mean follow-up of 10 months and a range of 0 to 17 months. Key highlights from the data include 35% of patients treated had complex AAA anatomies, only 0.7% of patients had an endoleak at the latest follow-up, and there was no device-related mortality. The company stated that these data continue to support very positive outcomes in a patient population that had no screening or anatomical restrictions at enrollment.

Early results from the registry were presented by Andrew Holden, MD, at the 41st VEITHsymposium held November 18–22, 2014, in New York, New York. Additional interim data are expected to be presented over the course of the 5-year follow-up period, with the next presentation anticipated in the fall of 2015.