FDA Approves New Cordis Carotid Stent
Recently, the FDA has approved the Cordis Precise RX Nitinol Self-Expanding Stent and ANGIOGUARD RX Emboli Capture Guidewire System for treatment of carotid artery stenosis (narrowing of the major blood vessels that lead to the brain). The advantage of this rapid exchange stent is that it allows a single operator to perform the procedure. Abbott Vascular, Boston Scientific and eV3 also market rapid exchange devices.
Carotid artery disease, a build up of plaque causing blockage in the carotid arteries, is a major cause of stroke. Stroke is the third leading cause of death in the United States and the leading cause of serious, long-term disability. Treatment of carotid artery disease includes medical management to decrease blood pressure, lower cholesterol and prevent blood from clotting with antiplatelet agents such as aspirin. Historically, when medical management failed the only other option was carotid endarterectomy (a surgical procedure to remove plaque from the carotid arteries). Approximately three years ago, physicians began performing a less invasive procedure using a catheter, balloon and stent. All carotid artery stents are used in combination with a filter device to capture any plaque that may dislodge during the procedure, travel to the brain and cause a stroke.
The Cordis PRECISE RX Nitinol Self-Expanding Stent and ANGIOGUARD RX Emboli Capture Guidewire System are approved to treat carotid artery disease in patients at high risk for complications from carotid endarterectomy.
Current Medicare coverage for carotid artery stents includes:
- “Those patients who are symptomatic (history of stroke or TIA) and have carotid artery blockage greater than 70%.
- Limited coverage in specified clinical trials situations for patients with no symptoms of carotid artery stenosis and who are at high risk for surgery.”
However, Medicare is currently considering expanding coverage for carotid artery stents to include patients who are without symptoms and have greater than or equal to 80 percent blockage. Due to potential safety concerns, coverage for patients 80 years or older will be restricted.
See also: Carotid Stents On the Rise.
February 20, 2007 Related topics: Legal & legislative, Product Approval & Certification, Psychiatry & Neurology, Cardiology