FDA Should Wait on Approving Xience Drug Coated Stent
April 23rd, 2008 joshua
The Food and Drug Administration (FDA) will soon be faced with a difficult decision regarding drug-eluting stents.
After the first year of a clinical trial on Abbot Vascular’s Xience stent, it outperformed the most popular such device, the Taxus. The Xience used a new kind of drug coating, according to an article at WebMD.com, and seems safer and more effective than Taxus.
The pressure is now on the FDA to either approve the Xience stent or wait until the trial continues longer. Doctors who used Taxus and other drug-eluting stents already on the market, that doctors over a bare metal stent began noticing blood clots at the site of the stent.
This led to repeat surgeries long after the stent was in the body and numerous reports of injuries due to this product defect. This is likely due to the FDA’s rush to approve drug-eluting stents, and shows that regulators should be wary of any early results from the clinical trial of Xience.
Drug-eluting stents are not really designed for patients with more advanced heart conditions, rather a simple clogged artery. Trouble with the first wave of stents were noticed mostly when they were used in patients whose bodies weren’t really ready to accept them.
