Two-Year Data From EVAS FORWARD IDE Trial Presented for Endologix's Nellix EVAS System
June 5, 2017—Endologix, Inc. announced the presentation of 2-year clinical data from the investigational device exemption (IDE) clinical trial of the company’s Nellix endovascular aneurysm sealing (EVAS) system. The EVAS FORWARD IDE trial evaluated prospectively enrolled patients with abdominal aortic aneurysms who were treated with the Nellix EVAS system.
The study’s Principal Investigator, Jeffrey Carpenter, MD, presented the results at the Society for Vascular Surgery's 2017 Vascular Annual Meeting, which was held May 31 to June 3 in San Diego, California.
According to Endologix, key data included rates of freedom from all endoleaks (94%), rupture (97%), all-cause mortality (97%), and cardiovascular mortality (99%) among all patients. The rate of freedom from type II endoleaks was 97% at 2 years among all patients. When applying the refined indications for use (IFU) for Nellix, patients at the 2-year follow-up demonstrated a 96% freedom from type Ia endoleak, migration, and sac growth.
In the company's announcement, Dr. Carpenter commented, “The overall 2-year results for EVAS with Nellix are very encouraging. In particular, the refined IFU appears to offer excellent patient outcomes, and we look forward to validating these results in the upcoming prospective confirmatory study.” Dr. Carpenter is Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in Camden, New Jersey.