FDAnews
www.fdanews.com/articles/71050-endotex-announces-european-approval-of-nexstent

EndoTex Announces European Approval of NexStent

April 13, 2005

EndoTex Interventional Systems announced CE Mark approval of its NexStent Carotid Stent and Monorail Delivery System, which provides a minimally invasive approach for treating carotid artery disease, avoiding the more invasive surgical procedure called carotid endarterectomy (CEA).

The NexStent system is a self-expanding stent that is specifically designed to adapt and conform to the unique anatomy of the carotid vasculature. This design is composed of a 30-mm length coiled sheet, Nitinol stent in a 5-French delivery system that allows the stent to not only take on a tapered or non-tapered configuration, but also allows the stent to self size to arterial diameters between 4 mm and 9 mm.

"The results from CABERNET suggest that CAS in this high-risk patient subset appears competitive with the major CEA trials. This innovative, sleek design delivered impressive results: a no nonsense, one size fits all stent," said Subbarao Myla, co-principal investigator of the CABERNET trial and Medical Director, CV Research and Vascular Intervention at Hoag Memorial Hospital.