Thirty-Day EVAS FORWARD-IDE Data Presented for Endologix's Nellix EVAS System

June 17, 2015—Endologix, Inc. announced the presentation of 30-day outcomes for the pivotal cohort from the company-sponsored EVAS FORWARD-IDE investigational device exemption (IDE) clinical investigation trial. EVAS FORWARD-IDE is 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). 

According to the company, EVAS FORWARD-IDE is a multicenter, prospective, single-arm clinical study with primary endpoints of major adverse events at 30 days (safety) and treatment success at 1 year (effectiveness). The study enrolled eligible patients with AAAs at 29 centers in the United States and Europe. After enrolling the first patient, each site enrolled patients to comprise the 150-patient pivotal cohort between February and November 2014. 

Protocol-defined follow-up at 1 month, 6 months, 1 year, and annually thereafter to 5 years includes a clinical assessment and high-resolution CT angiography (CTA) scans with core laboratory assessment for the presence of endoleaks, occlusion, migration, aneurysm stability, and device integrity.

The EVAS FORWARD-IDE clinical study’s National Principal Investigator Jeffrey P. Carpenter, MD, presented the 30-day findings at the Society for Vascular Surgery 2015 annual meeting in Chicago, Illinois. Dr. Carpenter is Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in Camden, New Jersey.

The company stated that key highlights from the presentation include 100% procedural technical success with few device-related serious adverse events; median fluoroscopy and procedure times of 10 minutes and 87 minutes, respectively; low 30-day mortality (0.7%) and overall major adverse events (2.7%), as adjudicated by an independent clinical events committee, with no aneurysm rupture or conversion to open repair; low incidence of any endoleak on the 1-month CTA scan (6%); and no lumen thrombosis, occlusions, or other device integrity issues.

In the Endologix press release, Dr. Carpenter commented, “I applaud the study investigators for their high degree of engagement in rapidly completing enrollment and in their careful attention to detail in this first United States multicenter experience with this new EVAS technology. The pivotal cohort procedural outcomes support the applicability and predictability of the Nellix EVAS procedure for patients with AAA. We are encouraged by the early results, and we look forward to completing the 1-year follow-up. Like many of our fellow investigators, we intend to continue enrolling patients in the continued access arm of the study to further build on the growing clinical evidence for the EVAS technology.”

Endologix advised that the Nellix EVAS system is a new generation of AAA therapy designed to seal the entire aneurysm sac. It is commercially available in Europe and select other international markets.

In the United States, the Nellix EVAS system is approved only for investigational use. The company expects to submit the premarket approval application to the US Food and Drug Administration in early 2016 and is anticipating approval of the Nellix system by the end of 2016.