IRVINE, Calif., April 29, 2015 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of updated clinical data from the Company's EVAS FORWARD – Global Registry, a post-market study that prospectively enrolled patients with abdominal aortic aneurysms ("AAAs") who were treated with the Nellix EndoVascular Aneurysm Sealing System ("Nellix EVAS System"). Professor Matt Thompson, MD, St. Georges Vascular Institute, London, one of the principal investigators of the EVAS FORWARD – Global Registry, presented the results at the Charing Cross Symposium in London. The System is approved for investigational use only in the United States.
Global Registry data includes a total of 300 patients with a mean follow-up of 10 months and a range from 0 to 17 months. Key highlights from the data included:
- 35% of patients treated had complex AAA anatomies.
- The number of patients with an endoleak at the latest follow-up was 0.7%.
- 0% device-related mortality.
Early results from the registry were presented last year in New York. These data continue to support very positive outcomes in a patient population that had no screening or anatomical restrictions at enrollment, and constitute the broadest range of aortic anatomies for any AAA study.
Prof. Thompson commented, "Results from the Nellix EVAS FORWARD – Global Registry continue to be very promising, including low rates of endoleaks, reinterventions and mortality. The early data is impressive, especially considering the limited experience that many investigators had with the EVAS technology and the broad range of AAA anatomies treated in the study."
From October 2013 to September 2014, clinical investigators enrolled 300 patients treated with the Nellix EVAS System at centers in Europe and New Zealand. The study includes core lab assessment of CT scans and independent physician adjudication of outcomes. Patients enrolled in the EVAS FORWARD – Global Registry will be followed for five years, with primary endpoints evaluating safety and effectiveness of the Nellix EVAS System at 12 months post procedure.
The Nellix EVAS System is a new generation of AAA therapy designed to seal the entire aneurysm sac. It is the first and only EVAS product and was developed to mitigate all types of endoleaks, improve stability and long-term patient outcomes. Additional interim data are expected to be presented over the course of the five-year follow-up period, with the next presentation anticipated in the fall of 2015.
John McDermott, Chairman and Chief Executive Officer of Endologix, said, "The Nellix EVAS FORWARD – Global Registry data continues to look promising and we are extremely pleased with the early results. The Nellix aneurysm sac sealing technology offers the potential to improve long-term durability and treat more AAA patients than EVAR devices. We sincerely appreciate the efforts of our clinical investigators and look forward to collaborating with them and other physicians to make Nellix available to more patients around the world in the years ahead."