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FDA approves nitinol stent for iliac artery disease
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Abbott announced FDA approval of a self-expanding nitinol stent system for the treatment of iliac artery disease.
The Absolute Pro Vascular Self-Expanding Stent System is 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 based approval on results from the MOBILITY trial, which tested the Absolute Pro stent in 151 patients with iliac artery disease. The primary endpoint was significantly lower than the performance goal, with a 9-month major adverse event rate of 6.1% vs. 19.5%, respectively. The major adverse event rate was defined as death due to any cause, MI, clinically driven target lesion revascularization and limb loss on the treated side.
“Iliac artery disease greatly impacts patients’ overall quality of life,” Tony S. Das, MD, FACC, director of peripheral vascular interventions at the Presbyterian Heart Institute in Dallas, said in a press release. “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, physicians now have an additional option that is proven safe and effective to treat many patients with this debilitating disease.”