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news.Flexible Stenting Solutions, a developer of vascular and biliary stents, has received CE Mark for its FlexStent biliary self expanding stent system. Stent sizes include a complete matrix of 5, 6, 7 and 8mm diameters with 30 through 120mm lengths in a six French delivery system.
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According to Flexible Stenting Solutions (FSS), the FlexStent biliary self expanding stent system is indicated for the palliative treatment of biliary strictures resulting from malignant neoplasms.
In addition to the CE Mark, FSS has submitted Section 510(k) notification to FDA and is awaiting 510(k) clearance for this system. FDA clearance will allow for the sale of the device in the US.
Janet Burpee, CEO of FSS, said: “Our FlexStent biliary self expanding stent system offers the physician a straight forward solution for biliary duct stenting. We currently have a reconstrainable system under development which will offer the gastroenterologist the additional security of knowing repositioning is at his/her fingertips.”