The status and future of carotid stenting: Who are the players and what is at stake?

The ongoing controversy regarding interventional treatment of carotid stenosis using intravascular stents involves not only identification of the appropriate clinical indications for this procedure, but also the adequacy of the regulatory processes involved with both the FDA approval of this technology and CMS reimbursement for the indicated population. The evolution of carotid stenting in the United States has been influenced by several interested parties, including the medical community, patient population and regulatory agencies, each with their own expectations and challenges. In this article, we describe the FDA approval and CMS coverage processes for carotid stenting with embolic protection, evaluate the effects of off-label use and medical practice on acceptance of this technology, and identify future challenges and approaches for both government and medicine.