Sunday, November 20, 2011

New Stent Type Has Rare But Potentially Serious Problem, FDA Investigates

The FDA says it is working with drug-eluting stent makers to better understand what makes the devices shrink or become deformed on rare occasions. A drug-eluting stent is a scaffold placed into narrowed, diseased peripheral or coronary arteries; it releases a medication to block cell proliferation, which helps prevent eventual reclogging of the blood vessel. The DES (drug-eluting stent) is placed during an angioplasty procedure.

The FDA (Food and Drug Administration) says it is working closely with Boston Scientific Corp. the makers of several devices, including the Ion and Promus. The Ion stent was approved by the FDA this year, while earlier in 2011 Boston submitted the Promus Element for approval.

The FDA said to Reuters news agency: "FDA is actively working with (drug-eluting stent) manufacturers, including Boston Scientific, to better understand longitudinal stent deformation with respect to its causes, predisposing underlying anatomic conditions, operator techniques that can reduce the likelihood of its occurrence, and treatment strategies should it occur."
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