ABBOTT PARK, Ill., March 7, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) approved the 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. Over time, iliac artery disease can progress to where patients have reduced walking ability, experience chronic pain and suffer permanent disability. This approval is supported by the MOBILITY (Omnilink Elite® or Absolute Pro Stent Used in the Iliac Artery) study, which demonstrated that Absolute Pro is safe and effective, even in patients with complex disease.
"Iliac artery disease greatly impacts patients' overall quality of life," said Tony S. Das, M.D., FACC, director, Peripheral Vascular Interventions, Cardiology Section, Presbyterian Heart Institute in Dallas, Texas, and co-principal 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, U.S. physicians now have an additional option that is proven safe and effective to treat many patients with this debilitating 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 Omnili