Most drug-coated stent use never approved by the FDA: NewsTarget.com

A recent report has shown that the majority of drug-coated stents installed in patients by doctors are being used in “off-label” cases -- that is, cases not approved by the Food and Drug Administration.

The report was released in the New England Journal of Medicine, and is a collation of several studies that show 60 percent of drug-eluting stents are applied multiple times in patients with critical health.

Drug-eluting stents, or wire mesh tubes that release a medicine over a period of time that is supposed to decrease risk of arterial plaque build up, are only approved by the FDA for use in patients who have only one blocked artery and no accompanying health problems.

The studies also show that patients who receive drug-eluting stents have a higher risk of developing blood clots, or suffering heart attacks, although it is unclear whether the elevated risk is due to the actual stents, or the patient’s already poor health.

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Most drug-coated stent use never approved by the FDA

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