Abbott's Absolute Pro Stent System Approved to Treat Iliac Artery Disease

March 7, 2012—Abbott Vascular (Santa Clara, CA) announced that the US Food and Drug Administration has approved the Absolute Pro vascular self-expanding stent system for the treatment of iliac artery disease. Absolute Pro vascular stent system is indicated for the treatment of patients with de novo or atherosclerotic lesions in the native common iliac artery and native external iliac artery. 

According to Abbott Vascular, Absolute Pro is a self-expanding nitinol stent system made with a flexible material to allow the stent to conform to challenging lesions. It also provides optimal stent visibility. The delivery system is designed to minimize friction during stent deployment and ensure precise stent placement at the lesion site.

Abbott Vascular stated that the approval is supported by results from the Absolute Pro arm of the MOBILITY trial, which demonstrated that the Absolute Pro device is safe and effective, even in patients with complex disease. MOBILITY is a prospective, nonrandomized, two-arm, multicenter study that evaluated the Absolute Pro (MOBILITY AP) and Abbott's Omnilink Elite (MOBILITY OE) in patients with iliac artery disease.

In the Absolute Pro arm, 151 patients with iliac artery disease were enrolled at 33 centers in the United States. The company reported that the study met its primary endpoint, with a 9-month major adverse event rate of 6.1% (P < .0001). This result was found to be significantly lower than the performance goal of 19.5%, which was developed from published literature on previous iliac artery stenting studies. The major adverse event rate was defined as death due to any cause, myocardial infarction, clinically driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s). The results of the Omnilink Elite arm of the study will be available later this year, advised the company.

“Iliac artery disease greatly impacts patients' overall quality of life,” commented Tony S. Das, MD, Coprincipal Investigator of the MOBILITY trial. “The goal of treatment is to open narrowed iliac arteries to restore blood flow to the legs, thereby alleviating pain and improving the patient's ability to walk farther and enjoy a more active lifestyle. With Absolute Pro, United States physicians now have an additional option that is proven safe and effective to treat many patients with this debilitating disease.”