A new crop of drug-coated stents is in the hopper, but given recent confusion over the extent to which these cardiac devices may cause an increased risk in blood clots, heart attacks or death, the FDA is considering longer post-approval studies.

An FDA panel in December decided the risk appears higher for blood clots, but a fresh round of studies and articles in the New England Journal of Medicine failed to clarify anything. At a cardiac conference yesterday, one FDA official proferred a plan.

“We can’t have had this two-day panel meeting and have heard all we heard [in December] and ignore it,” says Ashley Boam, the FDA’s branch chief for interventional cardiology devices, who adds that the agency is likely to start requiring up to five years of postapproval studies on drug-eluting stents. “However, we’re sensitive toward finding a middle ground.”

In a research note this morning, Larry Biegelsen of Prudential Equity writes that he looks for the FDA to require clinically relevant endpoints in pivotal trials, such as death and heart attacks, and for trials to last 12 months, instead of nine months. The FDA plans to issue a guidance document on this subject this spring.

You can read more in a report from The Wall Street Journal (subscription required).

[tags]Abbott Laboratories, Boston Scientific, Drug-Coated Stents, FDA, Johnson & Johnson, Medtronic[/tags]