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FDA clears FSS FlexStent Biliary Self Expanding Stent System

Flexible Stenting Solutions (FSS), a developer of peripheral arterial, venous, neurovascular and biliary stents, has received 510(k) clearance for an improved FlexStent Biliary Self Expanding Stent Delivery System and an expansion of Biliary stent sizes.

The FlexStent Biliary Self Expanding Stent System is indicated for the palliative treatment of biliary strictures resulting from malignant neoplasms.

The expansion of the FlexStent Biliary Stent size range provides the physician with additional options in the treatment of these strictures.

FSS’ nearly fully connected stent has always allowed for a straight forward, simple and accurate delivery.

The delivery system improvement builds on the already easy to use system assuring even lower deployment forces thus enabling the physician to quickly perform each deployment.

FSS CEO Janet Burpee said the modified FlexStent Biliary Stent Delivery System has been designed for improved manufacturing and lower stent deployment force.