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Law & Health Weekly

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Biliary Stents



Off-Label Stent Use: How Important Are FDA Approvals to Physicians?



April 19th, 2008

Given the recent investigation by the US Department of Justice into the marketing of biliary stents for off-label uses in the peripheral vasculature, obtaining FDA approval for device use in specific arteries could become a key focus for stent manufacturers. A recent study conducted by Millennium Research Group at the Society of Interventional Radiology 33rd Annual Scientific Meeting in Washington, DC found that a significant portion of surveyed physicians would increase their use of biliary stents if the device received FDA approval for use in the peripheral vasculature; some physicians said their use could increase by as much as 50%.

Although stents on the market are...


Source: Law & Health Weekly (2008-04-19)

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