EVAS FORWARD-IDE Data Reported for Endologix's Nellix EVAS System

May 26, 2016—Endologix, Inc. announced positive clinical data from the investigational device exemption (IDE) clinical trial of the company’s Nellix endovascular aneurysm sealing (EVAS) system. The multicenter, prospective, single-arm EVAS FORWARD-IDE clinical study is designed to evaluate the safety and effectiveness of the Nellix device for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).  

According to Endologix, the data from the EVAS FORWARD-IDE study demonstrated that the Nellix EVAS system met the study primary safety endpoint for major adverse events (MAE) at 30 days and the primary effectiveness endpoint for treatment success at 1 year.

The company reported that 150 patients in the pivotal cohort were treated at 30 centers in the United States and Europe between January and November 2014. The investigators achieved 100% procedural technical success. At 30 days, the MAE rate was 2.7%, achieving the primary safety endpoint and comparing positively to the Society for Vascular Surgery (SVS) open surgical repair control group rate of < 56%.

At 1 year, the treatment success rate was 94%, achieving the primary effectiveness endpoint and comparing favorably to the performance goal of > 80%. Freedom from all-cause mortality and AAA-related mortality were 96% and 99%, respectively. Freedom from device-related secondary interventions was 96.6%. Endoleaks were present in 3.1% of patients at 1 year.

Jeffrey P. Carpenter, MD, National Principal Investigator of the EVAS FORWARD-IDE clinical study, commented in the Endologix press release, “We are very pleased to report that the EVAS FORWARD-IDE study met its primary safety and effectiveness endpoints. The 1-year results are highly encouraging and demonstrate that low overall endoleaks can reduce secondary interventions. This is an important milestone towards achieving US Food and Drug Administration (FDA) approval and making the Nellix aneurysm sealing technology available to AAA patients in the United States.” Dr. Carpenter is Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in Camden, New Jersey.  

Dr. Carpenter will present the EVAS FORWARD-IDE data at the SVS 2016 Vascular Annual Meeting, held June 8-11 in National Harbor, Maryland.

The results from the EVAS FORWARD-IDE study were submitted to the FDA as part of the company's premarket approval submission for the Nellix EVAS system. The company advised that it is 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.