FDA Clears FSS FlexStent® Biliary Self-Expanding Stent System Range Extensions

In short

A few weeks ago we covered the announcement that FDA had cleared Flexible Stenting Solutions’ (FSS)  Flexstent® Iliac vascular configurations for marketing in USA. Now the company  has announced receipt of 510(k) clearance for an increased range of  sizes of its FlexStent® Biliary Self-Expanding Stent System, including 9 and 10 mm diameters in lengths up to 100 mm.


Flexible Stenting Solutions Inc. (FSS) is a leading developer of what it terms “third-generation” flexible peripheral arterial, venous, neurovascular and biliary stents. Its fully connected stent has coupled technology with clinical needs by providing an atraumatic, highly durable and fatigue resistant stent with superior radial stiffness, flexibility and conformability.

The company claims that expansion of the FlexStent® Biliary Stent size range provides the physician with additional options in the palliative treatment of biliary strictures resulting from malignant neoplasms. FSS’s nearly fully connected stent has always allowed for a straight forward, simple and accurate delivery. As always, the delivery system is easy to use assuring stent placement accuracy with low deployment forces.

Company comments

“We are committed to providing our novel, next generation self-expanding stents in many sizes and for numerous indications.” Janet Burpee, FSS’s CEO, commented. “This 510(k) clearance for the 9 and 10 mm diameters of the biliary stent furthers our commitment to providing physicians with a straight forward stenting solution.”

Source: Flexible Stenting Solutions Inc., Business Wire

FlexStent® is a registered trademark of Flexible Stenting Solutions, Inc.