Ask The Doctors: 08/07
This is a challenging question and the source of much media attention and controversy. The differentiation between "on-label" and "off-label" has do to with whether the U.S. Food and Drug Administration (FDA) determines that there is enough evidence of benefit and safety supporting a specific use of the product that this information should be on the package insert that comes with the drug or device. "Off label" uses for a stent could include treating bypass graft lesions or for lesions of a certain size not specified on the label. In general, "on-label" products have more data to support their use for those purposes.