FDA provides 510(k) marketing clearance for the FlexStent Biliary Self Expanding Stent System

Sep 17 2009

Flexible Stenting Solutions Inc. (“FSS”), a leading developer of next generation peripheral arterial and biliary stents, received 510(k) clearance for the FlexStent^® Biliary Self Expanding Stent System.

The FlexStent^® Biliary Self Expanding Stent System is indicated for the palliative treatment of biliary strictures resulting from malignant neoplasms. FSS’s nearly fully connected stent has coupled technology with clinical needs by providing a highly durable stent with superior radial stiffness and low chronic outward force. The key to the 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.

“We are very excited about receiving 510(k) marketing clearance and were thrilled to participate in the FDA’s STED review process,” Janet Burpee, FSS’s CEO, commented. She added, “We believe our unique platform technology will continue to provide needed clinical solutions in the interventional radiology, gastroenterology, neurovascular and cardiology device marketplace.”

The company has also received CE Mark authorization for the Biliary and Femoropopliteal FlexStent^® systems. FDA 510(k) clearance will allow expansion of current biliary device sale beyond Europe to the United States market.

www.flexiblestent.com