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It is marketed outside the United States for the treatment of renal and iliac artery disease under the brand name Advanta V12. The iCast balloon expandable covered stent (Getinge), as it is named in the iCARUS study, received FDA clearance in the United States in 2007 for the treatment of tracheobronchial strictures. iCast is FDA approved for the treatment of tracheobronchial strictures produced by malignant neoplasms.
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The Advanta V12 stent is not available in the United States. In Canada, the Advanta V12 covered stent indication excludes renal arteries. Renal approval includes 5–7-mm diameter Advanta V12 sizes. †The Advanta V12 covered stent system is indicated for restoring and improving the patency of iliac and renal arteries.
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Advanta V12 is identical to the iCast branded product in the United States. iCast is the name of the product in the United States. *Advanta V12 is the name of the product outside the United States.
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