Balloon expandable vascular stent for iliac artery disease gains PMA approval, Abbott Laboratories Inc. announced Aug. 7. The cobalt chromium stent is indicated for treatment of atherosclerotic iliac artery lesions with reference vessel diameters of 5 mm-11 mm and lesion lengths of up to 50 mm. FDA approval was supported by the firm’s 304-patient, nonrandomized MOBILITY study. The trial, which enrolled iliac artery disease patients with intermittent claudication or critical limb ischemia, compared the effectiveness of Omnilink Elite with Abbott’s Absolute Pro self-expanding iliac artery stent. Abbott says the study met its primary endpoint with a nine-month major adverse event rate of 5.4% for Omnilink Elite patients versus 6.1% for Absolute Pro, which was well below the primary endpoint goal of 19.5%. Major adverse events were defined as death due to any cause, heart attack, clinically driven target lesion revascularization and limb loss on the treated side.
The MOBILITY study “demonstrated that treatment with Omnilink Elite resulted in an increase in quality of life in a difficult-to-treat patient population that is reflective of real clinical practice,” said...
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