Cook Medical has announced FDA 510(k) clearance of its new Evolution Duodenal Controlled-Release Stent for treatment of gastric outlet obstruction caused by gastrointestinal cancers.
Cook claims the new stent will allow for more precise placement than existing solutions, and will conform to the patient’s duodenum to reduce the risk of migration.
From the press release:
The Evolution Duodenal Controlled-Release Stent, the only duodenal stent delivery system that allows for controlled release and recapturability, is designed to provide physicians with precise control and maneuverability to ensure proper placement and potentially reduce complications such as migration and perforation. The Evolution Duodenal stent is uniquely designed with 18 crowns at both the distal and proximal ends, which allow the stent to adapt to the natural curvature of the anatomy. The proximal and distal flanges are designed to reduce the risk of stent migration, while the patented Flexor® catheter with kink-resistant technology provides trackability and maneuverability for deployment in the difficult anatomy of the duodenum.