Protocol for Performing Extracranial Cerebrovascular ...
The Rapid Exchange (RX) Acculink Carotid Stent was approved in August 2004 and Xact Carotid Stent was approved in September 2005 for patients with carotid artery stenosis at high surgical risk. The FDA approval letter and Summaries of Safety and Efficacy Data are attached and more detailed information on the labeled indication is provided below. ................
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