FDA approves Absolute Pro stent system (Abbott) for PAD

The FDA has approved the Absolute Pro Vascular Self-Expanding Stent System, from Abbott, for the treatment of Iliac Artery Disease, a form of Peripheral Artery Disease (PAD) that affects the lower extremities. This approval is supported by the MOBILITY study, which demonstrated that Absolute Pro is safe and effective, even in patients with complex disease. Absolute Pro is a self-expanding nitinol stent system made of a flexible material designed to allow the stent to conform to challenging lesions. It incorporates advanced technologies for optimal stent visibility, with a delivery system that is designed to minimize friction during stent deployment and ensure precise stent placement at the lesion site. The FDA approval was supported by the results of the Absolute Pro arm of the MOBILITY trial, a prospective, non-randomized, two-arm, multi-center study that evaluated two Abbott stents, Absolute Pro and Omnilink Elite, 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 study met its primary endpoint, with a nine-month major adverse event rate of 6.1 percent (p<0.0001). this result was found to be significantly lower than the performance goal of 19.5 percent, 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, heart attack (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 in 2012.>