Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today the online publication of results from the pivotal prospective, multicenter clinical trial of the Company's Powerlink XL((R)) System for treatment of abdominal aortic aneurysm in large diameter proximal aortic necks. This publication follows the U.S. Food and Drug Administration (FDA) approval in October 2008 of the device and treatment algorithm as a safe and effective endovascular option in patients with infrarenal aortic necks up to 32 millimeters in diameter. The trial showed aneurysm exclusion in 100% of patients at the pivotal one-year follow-up timepoint, with no conversions to open surgical repair, no ruptures and no device migrations. In addition, core lab evaluations of one-year follow up results show 96% of patients had reduced or stable aneurysm sac diameters and there were no aneurysm related mortalities, no stent fractures or limb occlusions, and no Type III or Type IV endoleaks.
William D. Jordan Jr., MD, Chief of Vascular Surgery at University of Alabama at Birmingham, and study investigator in the Powerlink XL trial, said, "There is mounting clinical evidence demonstrating the significant benefits of anatomical fixation in the treatment of AAA, including the results from this study, which shows Powerlink XL's ability to effectively treat patients with large aortic necks. These results are particularly remarkable considering that 85% of the patients in the trial had challenging infrarenal aortic neck anatomies, such as severe thrombus and/or reverse taper, which are considered to be among the most difficult to treat during endovascular repair."
The study, which is titled "Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: Results of a prospective, multicenter trial," was published online on the Web site of the Journal of Vascular Surgery (JVS) and will published in an upcoming issue of JVS. The study was authored by William D. Jordan Jr., MD, William M. Moore, Jr., MD, Jim G. Melton, DO, O. William Brown, MD, JD, and Jeffrey P. Carpenter, MD. The 78-patient study was conducted at 13 centers across the United States according to FDA regulations and guidelines. The trial was designed to study the safety and effectiveness of the Endologix Powerlink XL device in the treatment of patients with large aortic necks up to 32 millimeters in diameter. This is the first FDA study to evaluate the effectiveness of the placement of the Powerlink single-piece bifurcated device on the native aortic bifurcation (anatomical fixation) together with the Powerlink XL proximal extension.
John McDermott, Endologix President and Chief Executive Officer, said, "We are very pleased to announce the publication of exceptional results from our Powerlink XL clinical trial, expanding the clinical evidence supporting the broad use of our products in patients with AAA. We believe these clinical outcomes utilizing Powerlink XL in difficult to treat patients will help increase our share of the large neck AAA market and also contribute to the transition of patients from open surgical to endovascular AAA repair."
Mr. McDermott concluded, "The successful outcomes achieved in the trial mirror what we have been seeing in the field as we leverage successful outcomes with Powerlink XL to introduce surgeons to our products and gain more of their everyday business. Adoption of Powerlink XL is also benefitting from the recent launch of the IntuiTrak Express Delivery System, which simplifies the procedure and is the lowest profile delivery system in the United States to treat AAA patients with aortic necks greater than 28 millimeters."