Consolidated Clinical Trial Results Published for Endologix Powerlink

April 28, 2010—Endologix, Inc. (Irvine, CA) announced the publication of consolidated results from its prospective, multicenter clinical trials of the company's Powerlink stent graft for the endovascular repair of abdominal aortic aneurysms (AAA) using an anatomical fixation technique. The study presents consolidated results from two previously published Powerlink studies and one additional Powerlink study that has been submitted for publication. Jeffrey P. Carpenter, MD, et al published the findings in the Journal of Endovascular Therapy (2010;17:153–162).

According to the company, the study reports the initial, midterm, and available long-term results for 157 patients treated with the Powerlink system at 28 centers across the United States according to FDA regulations and approved protocols. All patients received the Powerlink infrarenal bifurcated stent graft via the anatomical fixation technique, with concomitant proximal sealing achieved with a Powerlink aortic extension as dictated by patient anatomical needs.

The trial results demonstrate no aneurysm ruptures, no conversions to open repair, no device migrations, no stent fractures, no graft fatigue, no junctional endoleaks, no transgraft endoleaks, and 100% freedom from aneurysm-related mortality for up to 5 years after implantation. In addition, core lab evaluations found a low rate of limb occlusion (0.6% of limbs), with significantly reduced or stable aneurysm sacs in 95% and 93% of patients at 1 year and 5 years, respectively.

“The current and consolidated results of the anatomical fixation technique using the Powerlink system for the treatment of AAA provides further compelling evidence to clinically validate this treatment modality,” commented Dr. Carpenter. “The long-term results of the study, which include no device failures and significant reductions in aneurysm sac volume, compare favorably with existing clinical data using proximal fixation devices. The results are particularly positive considering that 83% of trial patients had hostile aortic neck anatomies, which can increase the risk that the procedure will fail. Moreover, given the known prevalence of peripheral arterial disease in AAA patients, preservation of the aortic bifurcation for future peripheral interventions is a clinically significant benefit of anatomical fixation compared with proximal fixation.”