Abbott nets FDA clearance for Omnilink stent for iliac artery disease

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The FDA has approved Abbott's Omnilink Elite vascular balloon-expandable stent system for the treatment of iliac artery disease, a form of peripheral artery disease that affects the lower extremities.

The FDA approval is supported by clinical data from the MOBILITY (O mnilink Elite or A bsolute Pro stent used in the Iliac Ar tery) study, which was presented at SCAI.12, and demonstrated that Omnilink Elite is safe and effective.

MOBILITY, a prospective, non-randomized, two-arm, multicenter study conducted at 48 centers in the U.S., evaluated the effectiveness of two Abbott stents in patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions. The two stents were the Absolute Pro vascular self-expanding stent system and Omnilink Elite vascular balloon-expandable stent system. Of the 304 patients enrolled in the study, 151 were treated with Absolute Pro and 153 were treated with Omnilink Elite.

The Omnilink Elite stent is based on the MULTI-LINK stent design with a cobalt chromium alloy.