The Food and Drug Administration expanded the indication for the RX Acculink carotid stent, allowing it to be marketed for use in patients with carotid artery disease who do not face an increased risk of complications from surgery.
The RX Acculink stent, which is marketed by Abbott Vascular, a subsidiary of Abbott Laboratories, was originally approved by the FDA in 2004. At that time, the stent was approved for patients at high risk of complications from carotid endarterectomy.
The company sought an expanded approval based on the results of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), a randomized, multicenter, noninferiority study sponsored by the National Institutes of Health and funded in part by the manufacturer.
The study of more than 2,500 patients in the United States and Canada showed that at 1 year, patients who were treated with RX Acculink had a combined 30-day rate of death, stroke, and myocardial infarction, and a 31 to 365-day rate of ipsilateral stroke, of 7.1%, compared with 6.6% among those who underwent endarterectomy, a difference that met the prespecified criteria for noninferiority.
As a condition of the expanded approval, the FDA is requiring Abbott Vascular to conduct a postapproval study. The study would follow new patients treated with RX Acculink for at least 3 years to confirm the results from the CREST study.
The FDA has also asked the manufacturer to look at how patients aged 80 years and older respond to treatment and whether patients who show symptoms prior to treatment experience different outcomes than those who don't exhibit symptoms.
The FDA's action follows a recommendation from the Circulatory System Devices Panel. In January, a majority of those experts voted that the benefits of using the RX Acculink stent outweighed the risks when used in patients at standard risk for surgery.