EndoTex to start pivotal carotid stent trial:
This article was originally published in Clinica
Executive Summary
The US FDA has given EndoTex Interventional Systems the go-ahead to begin a pivotal study of its NexStent self-expanding carotid stent. The study, called CABERNET, will enrol patients at high-risk for surgical carotid endarterectomy across 30 US and European sites. Following a series of deals between Endotex and Boston Scientific last year, the trial will test the stent together with Boston's filterwire embolic protection device. The agreements also provided for Boston to make an equity investment in Endotex and to gain an exclusive option to buy the firm. Boston will be the primary distributor for Cupertino, California-based Endotex in international markets.
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