Boston Scientific says U.S. investigating stent use

-twincities.com

02/28/2008 -The U.S. Department of Justice is conducting a civil investigation of allegations that Boston Scientific and other suppliers improperly promoted biliary stents for off-label uses, the Natick, Mass.-based company said Thursday in a regulatory filing.

Boston Scientific does not make biliary stents in Minnesota but has significant other operations in the Twin Cities. And two other manufacturers of the product are based here — Medtronic in Fridley and Ev3 in Plymouth. The disclosure in a Boston Scientific filing with the Securities and Exchange Commission did not list the names of other companies involved in the investigation.

Medtronic spokesman Joe McGrath said that as of midday Thursday his company had "not been contacted by the Department of Justice regarding the investigation." Julie Tracy, a spokeswoman for Ev3, said: "We don't know anything more than what they have in their disclosure, and we don't have any comment on their disclosure."

Biliary stents are metal or plastic flexible tubes used to prop open the bile duct in patients with obstructions related to pancreatic cancer. The treatment helps drain the biliary tract and keep the bile duct open, thereby relieving pain.

Last March, the Food and Drug Administration met with manufacturers of bile-duct stents — including representatives of Boston Scientific, Medtronic and Ev3 — to discuss the agency's concern that the device had wrongly been promoted for use in blood vessels.

The products had not been approved for vascular use, the agency said, noting that stents must undergo a more-extensive premarket approval process if they are being used in blood vessels rather than in the bile duct. The agency was concerned about increased reports of adverse events in patients who received biliary stents off-label for vascular therapy.

At the time, Boston Scientific, Medtronic and Ev3 officials all said they had not been promoting off-label uses for the bile-duct product.

Tracy, the Ev3 spokeswoman, said Thursday that following the FDA meeting in March, the agency asked companies to conduct audits of their promotion practices. Ev3 did so, she said, and responded to specific FDA questions.

"Subsequent to that, Ev3 received notice that we had adequately responded," Tracy said.

Bile-duct stents are a small market compared with stents used to prop open coronary arteries, such as the Taxus stent that Boston Scientific manufactures in Maple Grove. Last year, for example, Millennium Research Group estimated the U.S. market for approved-uses of biliary stents in 2006 was worth $37.6 million, whereas the worldwide heart stent market is worth billions.

Doctors have noted that many biliary stents that aren't approved for use in vascular procedures in the U.S. do have that approval in Europe.

In the company's filing Thursday, Boston Scientific said that while it had not received a subpoena for documents, the company intends to cooperate with the investigation.

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