EVAS Forward Global Registry Commences for Endologix's Nellix AAA Sealing System

October 30, 2013—Endologix, Inc. (Irvine, CA) announced the beginning of enrollment in the EVAS Forward global registry to evaluate the company's Nellix endovascular aneurysm sealing system, which is designed for the treatment of infrarenal abdominal aortic aneurysms (AAAs). The registry is one of a number of clinical studies planned by the company as part of its broader EVAS Forward clinical program aimed at establishing clinical and economic evidence for endovascular aneurysm sealing (EVAS).

According to Endologix, the EVAS Forward global registry will enroll 300 patients at up to 30 sites with 5-year follow-up in Europe and around the world in markets where Nellix is commercially available.

The company stated that as a new generation of AAA therapy, EVAS seals the entire aneurysm by injecting a biostable polymer into the aneurysm sac and that the Nellix EVAS device is targeted at the direct causes of reinterventions and is intended to expand the treatable patient population.

The Nellix device is approved for commercial use in Europe. The Nellix EVAS system has not been approved for clinical investigation or for sale and marketing in the United States. The company expects to receive approval for investigational use in the United States shortly, advised Endologix.

Andrew Holden, MD, performed implantation in the first global registry patient. Dr. Holden is Director of Interventional Services at Auckland City Hospital and Associate Professor of Radiology at Auckland University School of Medicine in New Zealand.

In Endologix's press release, Dr. Holden commented, “We are pleased to have the first patient enrolled in this important registry. The unique ability of Nellix to fill and seal an aortic aneurysm sac positions it as a significantly improved solution for AAA repair. We believe it has the potential to simplify the procedure, improve outcomes for patients, and become a new gold standard for the treatment of AAA. We look forward to collaborating with Endologix and other investigators as we work together to evaluate the full potential of this new technology.”