An FDA-appointed advisory panel to review drug-eluting stents could have detrimental effects on the $6 billion-a-year market, reports the Chicago Sun Times, but, according to columnist Francine Knowles, Morgan Stanley analyst Glenn Reicin claims there’s no cause for alarm.
FDA says more formally evaluate recent stent studies that linked DES to the development of blood clots within 18 months. European researchers have recently concluded that older and less expensive bare-metal stents, are safer than DES and result in less blood clotting.
Depending on the panel’s assessment, FDA could wind up redefining which patients should receive DES or the agency could order more clinical trials.
But Reicin doesn’t believe the “panel will conclude anything that would cause a market conversion away from [drug-coated stents]," he said in a research note.
The probable outcome, Reicin indicates, will be demand for more post-marketing studies and a requirement for longer patient treatment with Plavix, a blood thinner, given to patients treated with the stents.