Treatment of in-stent restenosis for saphenous vein grafts using intravascular brachytherapy: regulatory challenges and clinical application.

Treatment of in-stent restenosis using intravascular brachytherapy (IVBT) has been demonstrated to be successful and has become the standard of care for native coronary artery disease. Based on the current Food and Drug Administration (FDA) indications for use and the clinical demand to increase the scope of this form of therapy to include saphenous vein grafts for the Beta-Cath System (Novoste Corporation, Norcross, Georgia), we set out to obtain institutional approval for off-label use. Identification of institutional regulatory bodies and related procedures for obtaining off-label device use was performed. Additionally, the IVBT written directive proscription and patient informed consent forms were revised to accurately administer radiation dose and to disclose the regulatory status of using IVBT for this anatomic site. While the specifics are outlined in this report, this process and the resources needed to obtain institutional approval for off-label use are indicative of that to be expected at similar institutions.