Medical device company Cook Medical has the regulatory go-ahead to bring a new gastrointestinal stent to market.
Cook announced Food and Drug Administration clearance of its biliary controlled-release stent on Wednesday. The controlled-release system allows a physician to deploy or recapture the stent by squeezing a trigger on the handle. The medical device gives a “point of no return” alert to the physician when the stent is deployed too far to be recaptured.
The new stent was developed to for use in patients who have obstructions of the bile duct. Cook says approximately 35,000 metal biliary stents are placed each year to relieve symptoms associated such obstructions. The woven construction of the new Cook stent was designed to stay open and also to stay in place. It is the latest in Cook’s Evolution line of controlled-release stents.
“We are thrilled with this addition to the Evolution family,” Barry Slowey, global leader of Cook Medical’s Endoscopy division said in a statement. “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, clearing the product for the European market. Cook says more than 1,200 stents have been placed in patients since then. The Evolution biliary stent will be available across the United States in July.
Cook Medical is an Indiana medical device firm. Its endoscopic unit is based in Winston-Salem.