Abbott has received the US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee's favorable votes for expanding the indication of company's RX Acculink Carotid Stent System to include patients at standard surgical risk.
RX Acculink is approved for the treatment of symptomatic and asymptomatic patients at high risk of adverse events from carotid endarterectomy (surgery).
The FDA considers the panel’s advice in decision making if to expand RX Acculink’s current indication of including patients at standard surgical risk.
Abbott Vascular chief medical officer and Medical Affairs division vice president Charles Simonton said after a thorough review of the scientific evidence, they 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.
"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," Simonton said.
The committee’s recommendation followed a review of data from CREST (Carotid Revascularization Endarterectomy vs Stenting Tria, the prospective study conducted to date comparing stenting to surgery.