RX ACCULINK, used with the RX ACCUNET Embolic Protection System, was previously indicated for patients at high risk of adverse events from surgery.
This expanded indication is supported by the results of the carotid revascularization endarterectomy vs. stenting trial (CREST) study.
CREST was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), and was partially funded by Abbott.
The trial demonstrated that carotid artery stenting and carotid surgery had similar safety and long-term outcomes for standard-risk patients with symptomatic and asymptomatic carotid artery disease.
The company intends to seek expanded Medicare coverage for carotid stenting based on the CREST trial results.
In addition, Abbott intends to initiate a post-approval study of the RX ACCULINK Carotid Stent System in patients at standard surgical risk later this year, to assess clinical outcomes at 30 days and annually for three years.
