FDA Advisory Committee recommends expanded indication for Abbott's RX ACCULINK Carotid Stent System

Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted that, for symptomatic and asymptomatic carotid artery disease patients at standard surgical risk, there is reasonable assurance that the benefits of the RX ACCULINK® Carotid Stent System outweigh its risks (Yes: 7, No: 3, Abstain: 1). Currently, RX ACCULINK is approved for the treatment of symptomatic and asymptomatic patients at high risk of adverse events from carotid endarterectomy (surgery). The FDA will take into account the panel's advice in making its decision on whether to expand RX ACCULINK's current indication to include patients at standard surgical risk; the company expects a decision later this year.

"After a thorough review of the scientific evidence, we are pleased that the advisory committee concluded that less-invasive carotid artery stenting is as safe and effective as surgery for patients at standard surgical risk," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "If the FDA approves an expanded indication, carotid artery stenting would represent an important additional option for physicians as they work with their patients to determine the best individualized treatment approach."

The committee's recommendation followed a review of data from CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial), the largest prospective study conducted to date comparing stenting to surgery. CREST demonstrated that carotid artery stenting and carotid surgery had similar safety and long-term outcomes for patients with symptomatic and asymptomatic carotid artery disease who were at standard surgical risk. In an analysis of 2,307 standard-risk patients with symptomatic and asymptomatic disease, carotid artery stenting demonstrated non-inferiority to surgery for the primary composite endpoint of death, any stroke and myocardial infarction (heart attack) within 30 days of the procedure plus ipsilateral (same side) stroke from 31 to 365 days. The results showed 7.1 percent of stenting patients and 6.6 percent of surgery patients experienced an event, the difference being non-significant.