Medicare Announces Intention to Cover Carotid Artery Stenting in FDA-Required Postapproval Studies
On September 1, 2004, the Centers for Medicare and Medicaid Services announced it will expand coverage for participants in a US Food and Drug Administration (FDA)-mandated postapproval study for the newly approved carotid stenting device used for percutaneous transluminal angioplasty (PTA) of the carotid artery. This carotid stenting system is used to treat patients who are at very high risk of stroke and cannot have surgery for their occluded carotid artery. The FDA asked the study sponsor to complete the postapproval study as a condition of approval.