The additional sizes include 9 and 10 mm diameters in lengths up to 100 mm.
The FlexStent system is indicated for the palliative treatment of biliary strictures resulting from malignant neoplasms. Expansion of the size range is intended to provide physicians with additional options in the treatment of these strictures.
“We are committed to providing our novel, next generation self-expanding stents in many sizes and for numerous indications,” said Janet Burpee, CEO of Flexible Stenting Solutions, in the release. “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.”
Flexible Stenting Solutions is headquartered in Eatontown, N.J.
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