Flexible Stenting Solutions, Inc. (“FSS”), a leading developer of next-generation flexible stents, announced today it has received CE Mark (Conformité Européene) for its FlexStent™ Biliary Self Expanding Stent System. Stent sizes include a complete matrix of 5, 6, 7 and 8 mm diameters with 30 through 120 mm lengths in a 6 French delivery system.
The FlexStent™ Biliary Self Expanding Stent System is indicated for the palliative treatment of biliary strictures resulting from malignant neoplasms. The key to FSS stent technology is the integration of helically wound struts with helical flexible coils. The key to the delivery technology is simplicity, ease of use and placement.
Janet Burpee, FSS’s CEO, stated: “Our FlexStent™ Biliary Self Expanding Stent System offers the physician a straight forward solution for biliary duct stenting.” She added, “We currently have a reconstrainable system under development which will offer the gastroenterologist the additional security of knowing repositioning is at his/her fingertips.”
In addition to the CE Mark, FSS has submitted Section 510(k) Notification to U.S. Food and Drug Administration and is awaiting 510(k) clearance for this system. FDA clearance will allow for the sale of the device in the U.S.
Source: Flexible Stenting Solutions
published: March 3, 2009 in: Companies, Products, Regulatory, Specialty, Trauma