Monday, January 21, 2008

Tiny Metal Scaffolds (Stents) Used in Clogged Arteries Have Undergone Little Testing

BARNABY FEDER writes for the NY Times:
From 2003 through 2006, more than one million patients suffering from clogged arteries and veins in their torsos and legs received stents that had undergone scant testing for such uses, said Dr. William H. Maisel, a device safety specialist at Harvard Medical School.

The stents are tiny metal scaffolds inserted in blood vessels to improve circulation. But regulators have approved them only for helping to drain digestive fluids from the bile duct in cancer patients...

...Dr. Maisel said that the biliary stents are probably the best treatment option for many patients receiving them in various arteries but that the lack of rigorously collected data leaves patients and doctors somewhat blind to the extent of the risks and benefits.

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