FDA panel: Stents Safe for Low-Risk Patients Only

After studying various safety issues, the Food and Drug Administration of US has reported that the new stents are generally safe for low-risk patients but in others may have high risk of blood clots and other complications. The FDA panel, in a meeting in Maryland last December 8, is also urging the agency to issue warnings for patients, who have received stents, to take anti-clotting drugs for a year.

William H. Maisel of the Beth Israel Deaconess Medical Center in Boston, who chaired the panel, said "If you use the device outside that indication, you're going to have a higher incidence of complications."

Stents are tiny mesh-wire tubes that prop open clogged arteries after being cleared of fatty deposits. The original version are bare metals which are often coated by scar tissue after some time, thus narrowing the arteries once more. The new drug-coated version inhibits the growth of scar tissues and were shown to be more effective than the original version.

Stent manufacturers like Johnson and Johnson, Boston Scientific, Medtronic and others are earning a combined total of $5 billion in sales globally from their own brands of drug-coated stents alone.

But, a Cleveland Clinic study published last week found that the drug-coated devices raise the risk of clots as much as 500% compared with bare-metal stents. This report prompted the 21-member panel to review if the risks of these new stents outweigh the benefits of its use.

Some researchers including those from Boston Scientific Corp, on the other hand, believes that the health risk from the use of the new devices are still low compared to the risks presented by repeated procedures and bypass surgeries.

Shares of Johnson and Johnson fell 11 cents to $65.95, Boston Scientific fell 23 cents to $16.71 and Medtronic declined 10 cents to $53.43.