Cook Medical has announced that its Evolution® Duodenal Controlled-Release Stent was recently granted 510(k) clearance by the Food & Drug Administration (FDA). This new stent expands palliative care options for patients experiencing issues associated with malignant gastric outlet obstruction (GOO), a late stage complication of a variety of GI related cancers with pancreatic cancer being the most common cause. Studies indicate that as many as 50 percent of the malignancies involving the small intestine, including pancreatic, gastric, duodenal and cholangiocarcinoma, occur in the duodenum, the part of the small intestine connected to the stomach. The stent offers these patients a minimally invasive alternative to relieve the symptoms and potentially life-threatening complications resulting from duodenal obstruction, such as abdominal pain, vomiting, malnutrition and aspiration.
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.
For more information, visit www.cookmedical.com.