Endologix Completes Enrollment in the Nellix EVAS FORWARD-IDE Clinical Trial

November 18, 2014—Endologix, Inc. announced that it has completed patient enrollment in the EVAS FORWARD-IDE clinical trial, the company’s United States pivotal clinical trial designed to evaluate the safety and effectiveness of the Nellix endovascular aneurysm sealing (EVAS) system for the endovascular repair of infrarenal abdominal aortic aneurysms (AAAs). 

Primary endpoint analysis results at 1 year and beyond will be used to support the company’s premarket approval application to the US Food and Drug Administration for the Nellix EVAS system. Based on current assumptions and timelines, the company anticipates approval of the Nellix system before the end of 2016.

Endologix stated that the EVAS FORWARD-IDE clinical trial enrolled 179 patients at 29 centers in the United States and Europe. Enrollment under an extended investigation phase is anticipated to begin shortly and will continue during the pivotal trial follow-up period and premarket approval preparation/review process. Jeffrey Carpenter, MD, serves as National Principal Investigator of the EVAS FORWARD-IDE clinical trial.

In the company’s press release, Dr. Carpenter commented, “The Nellix IDE clinical trial is the first study to examine the safety and effectiveness of EVAS in patients in the United States. Nellix has the potential to be a breakthrough technology for the treatment of AAA because it is the only device that directly targets the primary cause of secondary interventions by sealing the entire aneurysm sac. We look forward to monitoring the trial patients during the follow-up period and remain optimistic that Nellix will improve patient outcomes and enable physicians to treat more patients in the future.” Dr. Carpenter is Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in Camden, New Jersey.

Robert Cuff, MD, an investigator in the Nellix pivotal trial added, “EVAS with Nellix holds the promise of being a significant advancement in the treatment of AAA. In the cases performed at our site, we found the Nellix procedure to be simple, predictable, and with good acute outcomes. Based upon our results so far, we expect that Nellix will significantly reduce endoleaks and provide meaningful clinical benefits for patients. We look forward to participating in the Continued Access phase of the IDE and offering Nellix to patients when it is commercially available in the United States.” Dr. Cuff is a vascular surgeon with Spectrum Health in Grand Rapids, Michigan.

According to the company, the Nellix EVAS system is designed to seal the entire aneurysm and improve patient outcomes. The Nellix device was developed to simplify procedures, minimize endoleaks, reduce reinterventions, and expand the treatable patient population. Endologix received European CE Mark approval for the Nellix EVAS system in the first quarter of 2013 and the commercial introduction of the product in Europe is currently underway. In the United States, the Nellix EVAS system is approved for clinical trial use only and is not approved for commercial use, advised Endologix.