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August 19, 2009
Trial Results Published for Endologix's Powerlink XL
August 20, 2009—Endologix, Inc. (Irvine, CA) announced the publication of results from the pivotal, prospective, multicenter clinical trial of the company's Powerlink XL system for treatment of abdominal aortic aneurysm in large diameter proximal aortic necks. William D. Jordan, Jr, MD, et al published the study online ahead of print in the Journal of Vascular Surgery. The 78-patient study was conducted at 13 centers in the United States. It was designed to study the safety and effectiveness of the Powerlink XL device in treating patients with large aortic necks up to 32 mm in diameter. This is the first US Food and Drug Administration (FDA) study to evaluate the effectiveness of the placement of the Powerlink single-piece bifurcated device on the native aortic bifurcation together with the Powerlink XL proximal extension, the company stated.
According to Endologix, in October 2008, the FDA approved 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% of patients at the pivotal 1-year follow-up timepoint, with no conversions to open surgical repair, ruptures, or device migrations. In addition, core lab evaluations of 1-year follow-up results showed that 96% of patients had reduced or stable aneurysm sac diameters, and there were no aneurysm-related mortalities, stent fractures or limb occlusions, or type III or type IV endoleaks.
"There is mounting clinical evidence demonstrating the significant benefits of anatomical fixation in the treatment of abdominal aortic aneurysm, including the results from this study, which shows Powerlink XL's ability to effectively treat patients with large aortic necks," commented Dr. Jordan. "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."
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