FDA to Probe Incidents of Shrinking Heart Stents

by Kathy Jones on  November 21, 2011 at 8:50 PM Medical Gadgets
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The US Food and Drug Administration has revealed that it is working closely with stent manufacturers in order to find the exact cause that makes the newer class of heart stents to shrink or lengthen on rare occasions.
 FDA to Probe Incidents of Shrinking Heart Stents
FDA to Probe Incidents of Shrinking Heart Stents

The FDA added that majority of such incidents have taken place in Promus and Ion devices made by Boston Scientific Corp.

While the Ion stent has been approved by the FDA to be marketed in the United States, Boston Scientific has submitted an application to market Promus stents as well.

In a statement made to the Reuters news agency, the FDA said, "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."

Source: Medindia

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