Boston Scientific Corp. said the U.S. Justice Department is investigating allegations the company and other suppliers of bile-duct stents promoted the devices for unapproved uses.
Boston Scientific, based in Natick, Mass., described the investigation as civil rather than criminal and said the company was cooperating with authorities. No subpoena has been issued, according to a filing with the U.S. Securities and Exchange Commission.
The stents are approved to treat obstructions in tubes that carry bile, a digestive fluid, to the intestines. The products had a U.S. market of about $40 million in 2007 for approved uses, according to Millennium Research Group, a market research firm based in Toronto. Bigger than similar devices for heart arteries, bile stents are often used in other locations, mainly in the legs, analysts said.
"Because the leg twists and flexes and stretches, the risk of stent fracture goes up," Christopher Warren, an analyst at Friedman, Billings, Ramsey & Co., said. "As that usage has increased, more negative incidents have occurred. The DOJ investigation is a natural progression."
Company spokesman Paul Donovan declined to comment.
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