RECENT STUDY DATA MUST BE EVALUATED TO FULLY DETERMINE CLOT RISK OF DRUG-ELUTING STENTS, FDA SAYS

The FDA needs to evaluate data in two recent studies before it can determine the true risk of blood clots in patients implanted with drug-eluting stents, the agency said in a Sept. 14 statement.

The FDA pointed to two studies that showed a risk of blood clotting, or thrombosis, in patients observed 18 months to three years after device implantation.

The agency will need to conduct a more formal evaluation of the study results to "fully characterize" the mechanism, risks and incidence of drug-eluting stent thrombosis, it said.

The FDA believes that drug-eluting stents "remain safe and effective when used in patients having clinical and coronary anatomic features similar to those treated in the pivotal trials conducted by the manufacturers for FDA approval," the agency said, referring to Cordis' Cypher and Boston Scientific's Taxus stents.

To view the statement, go to www.fda.gov/cdrh/news/091406.html (http://www.fda.gov/cdrh/news/091406.html).