Devices & Diagnostics

Cook Medical’s GI stent granted FDA 510(k) clearance

A gastrointestinal stent from Cook Medical now has 510 (k) clearance from the U.S. Food […]

A gastrointestinal stent from Cook Medical now has 510 (k) clearance from the U.S. Food and Drug Administration for use in patients suffering GI obstructions caused by cancer.

Bloomington, Indiana-based Cook said that its Evolution Duodenal Controlled-Release Stent will be available for patients experiencing gastric outlet obstruction (GOO), a late-stage complication of GI-related cancers. Pancreatic cancer is the primary cause of GOO, though other cancers can cause the condition. Symptoms and complications of the obstruction include abdominal pain, vomiting and constipation.

Bypass surgery is one option to treat GOO, though surgery comes with risks and not all patients who undergo surgery report sufficient relief of their symptoms. Stents offer an alternative and work by alleviating obstructions in the duodenum, the part of the small intestine that connects to the stomach.

Cook’s new stent will compete with other stents on the market. But Cook, which has its GI unit in Winston-Salem, North Carolina, said that its stent can give doctors greater control and maneuverability within the curvature of the duodenum. The stent is also designed to better stay in place, reducing the risk of perforating the intestines.

Cook aims to back up its claims with data. In a European study, the company said 21 of 23 patients experienced “significant improvement” with its stent. A separate study of 110 patients has enrolled and analysis of data is under way.

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