FDA to review uses of bile-duct stents.

FDA has called a meeting with makers of bile-duct stents to discuss their heavy use for unapproved, or "off label" surgical applications, according to a "Wall Street Journal" article, March 10.

Officials of some stent makers said they fear FDA will threaten to slow new approvals of the devices or require more-rigorous testing in advance of approval. The meeting, scheduled this week, occurs as FDA, Medicare, and a congressional committee are also looking into off-label use of drug-coated coronary stents amid concerns about their risks in clotting.

An FDA spokeswoman confirmed a meeting but wouldn't say what was to be discussed. The meeting is expected to include manufacturers Boston Scientific, Johnson & Johnson, Abbott Laboratories, ev3, C.R. Bard, and Alveolus, the Journal reported.

Tiny bile-duct scaffolds, known formally as biliary stents, are supposed to prop open the tubes that carry digestive fluids to the intestines, as opposed to blood-pumping arteries, which are the province of stents approved for vascular uses, including drug-coated coronary stents used near the heart.

But since biliary stents are available in much larger sizes than their vascular cousins, doctors commonly use them to prop open large arteries, such as those leading to the legs and kidneys.

A September 2006 article by an FDA scientist also concluded that "virtually all" kidney-artery operations used stents not approved for that purpose.

Some industry sources estimate that as much as 90% of biliary stents are sold to catheterization laboratories and used off-label in arteries.

Since biliary stents are largely intended for patients dying of cancer and aren't tested in arteries, FDA requires far less rigorous study before approving a new biliary stent than one intended for vascular use.

A 2003 article by an FDA scientist questioned whether the "booming" biliary stent market was a result of rising needs in cancer patients or represented manufacturers' response to high off-label demand.

In 2004, FDA forced J&J's Cordis unit to recall an instruction sheet, which wasn't approved by FDA, for its Precise biliary stent after nine off-label patients were injured.