Endologix Reports Clinical Data on the Nellix EVAS System

June 9, 2016—Endologix, Inc. announced positive clinical data from the retrospective, multicenter Italian Research Nellix Endoprosthesis (IRENE) study, which is evaluating the company’s Nellix endovascular aneurysm sealing (EVAS) system for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA). IRENE Investigator Fabio Verzini, MD, presented the data at the Society for Vascular Surgery’s 2016 Vascular Annual Meeting in National Harbor, Maryland. Dr. Verzini is from the University of Perugia in Perugia, Italy.

According to Endologix, the IRENE study enrolled 335 consecutive elective patients at 16 centers throughout Italy between September 2013 and November 2015. Of the 244 patients available at 1-year follow-up, 88% were treated within the device’s instructions for use. Those procedures achieved 100% technical success. 

At 1 year, the IRENE investigators reported a 0.9% rate of all-cause mortality, a 2.4% rate for the overall incident of endoleaks, a 0.9% rate of limb occlusion, a 4.4% rate of secondary intervention, no ruptures, and no migration.

In his presentation, Dr. Verzini concluded, “These data support the adoption of EVAS with Nellix in the real world setting, including in patients who are more susceptible to type II endoleaks.”

IRENE Principal Investigator Bruno Gossetti, MD, added in the Endologix announcement, “We are very pleased with the initial procedural results and outcomes using Nellix in Italy in a wide range of AAA anatomies in a nonselected population and within high instructions-for-use compliance. The low endoleak, graft occlusion, and AAA-related reintervention rates are very encouraging.” Dr. Gossetti is from the University of Rome La Sapienza in Rome, Italy. 

Also at the Vascular Annual Meeting, Jeffrey P. Carpenter, MD, will discuss positive clinical data from the EVAS FORWARD-IDE investigational device exemption clinical trial. Endologix announced the data on May 26.

The multicenter, prospective, single-arm EVAS FORWARD-IDE trial is evaluating the safety and effectiveness of the Nellix EVAS system for the endovascular repair of infrarenal AAA. The data demonstrated that Nellix met the study primary safety endpoint for major adverse events at 30 days and the primary effectiveness endpoint for treatment success at 1 year.

The results from the EVAS FORWARD-IDE study were submitted to the US Food and Drug Administration as part of the company's premarket approval submission for the Nellix EVAS system. The company advised that it expects to receive potential FDA approval for the Nellix EVAS system at the end of 2016 or early 2017. Nellix is an investigational device in the United States.