FDA Clears Cook GI Stent

Bloomington, Ind.-based Cook Medical Inc. has received 510(k) clearance from the U.S. Food and Drug Administration for the Evolution biliary controlled-release uncovered stent. The biliary stent adds to Cook’s line of Evolution controlled-release stents for the gastrointestinal tract. According to the company, it is the only delivery system that allows the stent to be deployed or recaptured as needed, putting control in the physician’s hands.

Approximately 35,500 metal biliary stents are placed each year to relieve symptoms associated with obstruction of the bile duct. The woven construction of the Evolution biliary stent is designed to maintain patency and specifically to help prevent stent migration after placement.

Cook’s family of Evolution stents reportedly has a delivery system that allows a physician to deploy or recapture the stent in equal increments by squeezing the trigger on the handle. A “point of no return” mark alerts the physician when the stent is deployed too far to be recaptured. The system also features Cook’s Flexor Plus technology, which is meant to help the device remain flexible yet firm enough to be navigated through difficult paths in the anatomy.

“We are thrilled with this addition to the Evolution family,” said Barry Slowey, global leader of Cook Medical’s Endoscopy division. “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 received CE Mark in the spring of 2012, and more than 1,200 stents have been placed in patients since then. The Evolution biliary will be available throughout the United States in July. The Evolution line of stents includes biliary, colonic, duodenal and esophageal options.

Cook Medical focuses on medical devices, biologic materials and cellular therapies.