FDA Expects to Toughen
Coated-Stent Guidelines

The Food and Drug Administration expects to issue new testing requirements in the next few weeks for drug-coated heart stents, the agency's device chief, Daniel Schultz, said.

The revised guidelines come after some researchers have expressed fears that drug-coated stents may cause serious complications. The FDA held a two-day meeting last December over concern that coated stents increase the risk of blood clots years after implantation. After a year of study, it still isn't clear whether they increase late clots, but coated stents don't appear to increase deaths or heart attacks when compared with plain stents.

Stents prop open clogged arteries to relieve chest pains from heart disease. Models coated with drugs to reduce reclogging, from Boston Scientific Corp., of Natick, Mass., and Johnson & Johnson, of New Brunswick, N.J., account for most of the U.S. market.

The new FDA guidelines, which are expected to be more stringent than those currently in force, will probably cover items such as the numbers of patients on whom new stents must be tested and for how long. The rules may extend to the periods both before and after the FDA approves a stent for sale to the public. The guidelines may also discuss the recommended time that patients should take the anticlotting drug Plavix after getting a new stent.

The FDA's bar for approval can affect how much companies spend on studies as well as the level of certainty doctors and patients can have that stents are safe and effective.

The guidelines aren't expected to affect stents already on the market or models from Minneapolis-based Medtronic Inc. and Abbott Laboratories, of Abbott Park, Ill., that appear to be on the verge of approval.

***C.B!!! Chao Ang Mohs confirm got "kap". Just after MDT and ABT will get their approval FDA raise the bar for BIG, the next DES on the verge of obtaining FDA IDE. Why not do it before MDT and ABT as well? The blood clot problems was widely discussed since early 2006 and now then they want to scrutinise it for approval. FDA and large medical device companies operate like mafia incorporated. Continue to approve stents with late-thrombosis (Xience) and allow selling of problematic first generation DESs (Cypher and Taxus) and stop newer and better late thrombosis-free DES Biomatrix from entering the US market earlier. Focking bast#rds!!!