Cook Medical has received the 510(k) approval from the US Food and Drug Administration (FDA) for its Evolution Biliary Controlled-Release Uncovered Stent.
Adding to the Cook's line of Evolution controlled-release stents for the gastrointestinal (GI) tract, the new biliary stent is the only delivery system that allows the stent to be deployed or recaptured as needed, putting control in the physician's hands.
Cook Medical Endoscopy division global leader Barry Slowey said, "Now clinicians can experience the same precision and control throughout the entire GI tract, from the esophagus to the colon."
The Evolution biliary uncovered stent got CE mark in 2012, and so far, over 1,200 stents have been placed in patients. The Evolution biliary will be available across the US in July. This line of stents includes biliary, colonic, duodenal and esophageal options.
