An FDA advisory panel has backed expanding the indication for Abbott Laboratories’ RX Acculink Carotid Stent System to include use in lower-risk carotid endarterectomy patients. The Circulatory System Devices Panel voted 7–3, with one member abstaining, that expanding the indication for the stent system outweighs the risks. The panel also voted 6–4, with one abstention, that the system is safe for patients at standard risk of adverse events and 8–2 that the device is effective.
Devices & Diagnostics Letter