Drug Coated Stents to Get More Scrutiny from FDA Prior to ApprovalDec 14, 2007 | Parker Waichman LLP
Drug Coated Stents will soon be subject to more stringent testing requirements. The U.S. Food and Drug Administration (FDA) is planning to release new testing requirements for drug-coated heart stents in the next few weeks, the regulatory agency's device chief, Daniel Schultz, told the Wall Street Journal. In an article on Friday, the Journal reported that the FDA's revised requirements are in response to safety concerns about the drug-coated stents.
Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following procedures.
Drug-coated stents, made by companies including Boston Scientific Corp., Johnson & Johnson, and Medtronic Inc., were once a near $6 billion a year market, but that figure has fallen sharply amid concerns stents could cause complications. Some patients developed blood clots months after having the devices implanted so many doctors reverted to older and cheaper bare-metal stents. The FDA's new guidelines will likely be stricter concerning time framing for when patients should take an anti-clotting drug after receiving a new stent and regarding the number of patients and time used when testing new stents. Under the new guidelines, the testing period could go on before and after the FDA approves the project. The more stringent guidelines are not likely to affect stents that are already on the market.
A previous study, conducted by Swiss researchers and with results released last month, stated that the expensive drug-coated stents are not worth using in many patients; however, they can be cost-effective in a subset of heart patients who have particularly narrow vessels. The devices are designed to prevent arteries re-narrowing as often happens with bare metal stents, but their use has dropped recently because of fears that deadly blood clots can form inside the devices in rare cases. The findings are a result of an 18-month study of 826 patients and presents a less favorable value-for-money picture than previous research and—as expected—stoked fresh controversy over when to use drug stents.
Targeted stent use could be the preferred strategy today; lower prices of drug-eluting stents alone are unlikely to result in such stents being cost effective in all patients, even if the problems of late stent thrombosis are solved with new generations of drug-eluting stents, researchers concluded.
The Swiss team calculated that overall long-term treatment costs were higher with drug stents, at an average 11,808 euros—or $17,020—compared to 10,450 for bare metal stents. Rates of major adverse cardiac events or death were no different between the two groups. Since 2004, prices have fallen but the cost of bare stents has decreased more than for drug-coated ones, so the discrepancy between the two types has widened. A key review of the cost-effectiveness of the devices by Britain's National Institute of Health and Clinical Excellence (NICE) alarmed manufacturers in August with an initial proposal that drug stents were not worth using on the state health service.
Stents are a multibillion-dollar business for companies like Boston Scientific and Johnson & Johnson, who make the two drug-eluting stents assessed in the Swiss study.