FDA Approves Abbott Vascular's Omnilink Elite to Treat Iliac ... | 合法醫療器材資訊網

2012年8月6日—ThecompanystatedthattheFDAapprovalissupportedbyclinicaldatafromtheMOBILITY(OmnilinkEliteorAbsoluteProStentUsedintheIliac ...

August 7, 2012—Abbott Vascular (Santa Clara, CA) announced that the US Food and Drug Administration (FDA) approved the Omnilink Elite vascular balloon-expandable stent system for the treatment of iliac artery disease. In the United States, the Omnilink Elite is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of ≥ 5 mm and ≤ 11 mm, and lesion lengths up to 50 mm. The Omnilink Elite is now available in the United States, Europe, the Middle East, and parts of Asia, with indications varying by geography.

The Omnilink Elite stent is based on the companys Multi-Link stent, with a next-generation cobalt chromium alloy designed to provide more strength and radiopacity than stainless steel and more visible under x-ray.

The company stated that the FDA approval is supported by clinical data from the MOBILITY (Omnilink Elite or Absolute Pro Stent ...