Endologix has completed patient enrolment in the EVAS FORWARD – Global Registry. From October 2013 to September 2014, the registry enrolled 300 patients treated with the Nellix EndoVascular Aneurysm Sealing (EVAS) System at centres in Europe and New Zealand. The registry will provide real-world clinical results to further demonstrate the effectiveness and broad applicability of the Nellix technology.
The primary investigators of the registry are Andrew Holden, associate professor of Radiology at Auckland Hospital, and Matt Thompson, St Georges Vascular Institute, London.
Thompson, said, “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 EVAR 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.”
Patients enrolled in the EVAS FORWARD – Global Registry will be followed for five years, with a primary endpoint evaluating safety and effectiveness of the Nellix EVAS System at 12 months post procedure. Interim data from the registry is expected to be presented over the course of the five year follow-up period. The next data presentation from the registry is anticipated at the VEITH symposium in November 2014. Holden is expected to present data from the first 250 patients enrolled in the trial, which will include results at 30-days post procedure or greater.
John McDermott, chairman and chief executive officer of Endologix, said, “We are pleased to have completed patient enrolment in the EVAS FORWARD – Global Registry ahead of our original expectations. The rapid enrolment is indicative of the strong physician interest in and broad applicability of the Nellix EVAS System. In the USA, we also continue to make excellent progress with the EVAS FORWARD – IDE clinical trial, which has now enrolled 125 patients and remains on track to complete enrollment by the end of the year.”