Updated on 9 August 2012
Of the 304 patients enrolled in the study, 151 were treated with Absolute Pro and 153 were treated with Omnilink Elite. The study met its primary endpoint, which was a nine-month major adverse event rate of 6.1 percent for patients treated with Absolute Pro and 5.4 percent for patients treated with Omnilink Elite. These rates were significantly below the primary endpoint goal of 19.5 percent (p<0.0001), which was developed from published literature on previous iliac artery stenting studies.
Dr Charles A Simonton, divisional vice president, medical affairs, and chief medical officer, Abbott Vascular, said that, "Low rates of target lesion revascularization and significant improvements in walking ability reinforce the use of Omnilink Elite in real-world patients. The approval of Omnilink Elite and the recent FDA approval of Absolute Pro add to Abbott's already robust portfolio of advanced endovascular products for the treatment of PAD."