Advertisement
Advertisement
May 5, 2011
FDA Expands Indication for Abbott Vascular's RX Acculink for CAS on Standard-Risk Patients
May 6, 2011—Abbott Vascular (Santa Clara, CA) announced that the US Food and Drug Administration (FDA) expanded the approval of the RX Acculink carotid stent system for use in the endovascular treatment of patients with carotid artery disease who are at standard risk for adverse events from carotid endarterectomy (CEA). RX Acculink was previously indicated for patients at high risk for adverse events from surgery. RX Acculink is intended for use with the RX Accunet embolic protection system.
According to the company, this expanded indication is supported by the results of the CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) study, which the company submitted to the FDA. CREST is the largest prospective study conducted to date comparing carotid artery stenting (CAS) to CEA. CREST was sponsored by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, and was partially funded by Abbott. The trial demonstrated that CAS and CEA had similar safety and long-term outcomes for standard-risk patients with symptomatic and asymptomatic carotid artery disease.
"The CREST data demonstrated that CAS is a safe, effective, and minimally invasive treatment for standard-risk patients with carotid artery disease," commented L. Nelson Hopkins, MD. "With this broader indication, the RX Acculink carotid stent system will become an important option for physicians as they determine the most appropriate treatment approach for their patients."
Abbott Vascular stated that it intends to seek expanded Medicare coverage for CAS based on the CREST trial results. In addition, the company plans to initiate a postapproval study of the RX Acculink carotid stent system in patients at standard surgical risk later this year. The study is planned to assess clinical outcomes at 30 days and annually for 3 years, the company advised.
Advertisement
Advertisement
