Originally created 10/25/02

FDA advisers recommend new drug-coated heart stent



WASHINGTON -- A new type of stent that props open clogged heart arteries and keeps them open by emitting a drug moved a step closer to the market Tuesday.

Advisers to the Food and Drug Administration voted unanimously late Tuesday that Johnson & Johnson's Cypher stent should be approved for sale - if the company meets a list of conditions.

Among them: Mandating that the stent is intended to clear only certain-sized blockages; providing clearer information for doctors and patients about the stent's effects; and promising to follow for five years people who initially tested the stent to see how it holds up long-term.

The committee noted that the stent is coated with a drug - sirolimus, normally used to prevent organ rejection in kidney transplants - that cardiologists aren't familiar with, said Dr. Ashley Boam, FDA's chief of interventional cardiology. Thus, there are some questions about side effects and interactions with other heart drugs.

The panel did say the stent "will be an important advance," Boam said.

The FDA isn't bound by its advisers' recommendations but usually follows them.

During an angioplasty, cardiologists use a balloon to push aside heart disease-causing clogs. Then stents, a type of metal scaffolding, often are inserted to help keep the artery from re-clogging.

They're not perfect, though, so scientists are coating stents with certain medications in an effort to make them work better. One stent coated with blood-thinning heparin has already been approved by the FDA.

The theory behind Johnson & Johnson's Cypher stent is the sirolimus coating may help control inflammation, thus fighting a new clog, when the artery slowly absorbs some of the drug.

In one study, more than 90 percent of people who received a Cypher stent had no further heart trouble in the following six months, compared with 73 percent who got a regular drug-free stent.

On the Net:

Food and Drug Administration: http://www.fda.gov/

Johnson & Johnson: http://www.jnj.com