August 21, 2009 – Endologix Inc. yesterday announced the online publication of results from the pivotal prospective, multicenter clinical trial of the company's Powerlink XL System for endovascular treatment of abdominal aortic aneurysm in large diameter proximal aortic necks.
This publication follows the 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 mm in diameter. The trial showed aneurysm exclusion in 100 percent of patients at the pivotal one-year follow-up, 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 percent 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.
"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,” said William D. Jordan Jr., M.D., chief of vascular surgery at University of Alabama at Birmingham, and study investigator in the Powerlink XL trial. “These results are particularly remarkable considering that 85 percent 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 and will published in an upcoming print issue of JVS. The study was authored by William D. Jordan Jr., M.D., William M. Moore, Jr., M.D., Jim G. Melton, DO, O. William Brown, M.D., JD, and Jeffrey P. Carpenter, M.D. 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 mm 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.
For more information: www.endologix.com