Drug Coated Stents Used for Off Label Procedures

In an article published in the Wall St. Journal, drug coated stents are being used for procedures which are not approved by the FDA. Obviously, with off-label use the risk to the patient is greater since the potential consequences are unknown or harmful. The Food and Drug Administration has approved two coated stents for straightforward cases, one by Johnson & Johnson and the other by Boston Scientific Corp. However, the stents have not been approved for the more complicated cases.