The US Food and Drug Administration (FDA) has granted 510(k) clearance to Flexible Stenting Solutions' additional sizes of FlexStent Biliary Self-Expanding Stent system including 9 and 10mm diameters in lengths up to 100mm.
The FlexStent Biliary Stent system is intended to be used for the palliative treatment of biliary strictures resulting from malignant neoplasms.
In addition to biliary stents, the company develops third-generation flexible peripheral arterial, venous, neurovascular stents, which provides an atraumatic, durable and fatigue resistant stent with superior radial stiffness, flexibility and conformability.
Flexible Stenting Solutions CEO Janet Burpee said the company is committed to provide its next generation self-expanding stents in many sizes and for numerous indications.
"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," Burpee added.