Endologix Completes Enrollment in EVAS FORWARD—GLOBAL Registry of Nellix System

September 29, 2014—Endologix announced that it has completed patient enrollment in the EVAS FORWARD—GLOBAL registry, which enrolled 300 patients treated with the company’s Nellix endovascular aneurysm sealing (EVAS) system at centers in Europe and New Zealand from October 2013 to September 2014. The registry will provide real-world clinical results to further demonstrate the effectiveness and broad applicability of the Nellix technology, stated the company.

The EVAS FORWARD—GLOBAL registry primary investigators are Andrew Holden, MD, and Prof. Matthew Thompson, MD. Dr. Holden is associate professor of radiology at Auckland Hospital in Auckland, New Zealand, and Prof. Thompson is from St. Georges Vascular Institute in London, United Kingdom.

In the company’s press release, Prof. Thompson commented, “The EVAS FORWARD—GLOBAL registry is the first large prospective study to examine the safety and effectiveness of EVAS with the Nellix system. This promising new technology allows physicians to treat a broader range of patients, including many that would not have previously been candidates for the currently available endovascular aneurysm repair devices. We have been very pleased with our initial experience and believe that Nellix has the potential to become a leading therapy for patients with abdominal aortic aneurysms.”

The company advised that patients enrolled in the EVAS FORWARD—GLOBAL registry will be followed for 5 years, with a primary endpoint evaluating the safety and effectiveness of the Nellix EVAS system at 12 months postprocedure. Interim data from the registry are expected to be presented during the 5-year follow-up period. The next data presentation from the registry is anticipated to take place at the VEITH symposium, to be held November 18–22, in New York, New York. Dr. Holden is expected to present data from the first 250 patients enrolled in the trial, which will include results at ≥ 30 days postprocedure.

In September 2012, the Nellix EVAS system received European CE Mark approval. In January 2013, an enhanced version of the Nellix system received CE Mark approval.

In December 2013, the company announced that it received investigational device exemption (IDE) approval from the US Food and Drug Administration to begin a pivotal clinical trial to evaluate the safety and effectiveness of the Nellix EVAS system. The pivotal trial, EVAS FORWARD—IDE, has enrolled 125 patients and is expected to complete enrollment by the end of the year, noted the company.