The U.S. Food and Drug Administration (FDA) has approved Abbott's Absolute Pro Vascular Self-Expanding Stent System for the treatment of iliac artery disease, a form of peripheral artery disease (PAD) that affects the lower extremities.
The self-expanding nitinol Absolute Pro stent system is made of a material designed to allow the stent to conform to challenging lesions, said the company.
The Absolute Pro offers optimal stent visibility, and includes a delivery system that is designed to minimize friction during stent deployment and ensure precise placement at the lesion site.
The FDA approval is supported by the results of the Absolute Pro arm of the Mobility trial, which demonstrated the safety and effectiveness of Absolute Pro, even in cases with complex disease.
The Absolute Pro arm trial enrolled 151 patients with iliac artery disease at 33 centers in the US. The study achieved its primary endpoint, with a nine-month major adverse event rate of 6.1%.
The Abbott’s Absolute Pro stent is indicated for the treatment of patients with de novo or atherosclerotic lesions in the native common iliac artery and native external iliac artery.