FDA Clears Cook’s Evolution® Biliary Controlled-Release Uncovered Stent

Cook Medical Evolution Biliary StentCook Medical has received  FDA 510(k) clearance for its Evolution® Biliary Controlled-Release Uncovered Stent. The company says its device is the only delivery system that allows the stent to be deployed or recaptured as needed, putting control in the physician’s hands.

Background

Approximately 35,500 metal biliary stents are placed each year¹ to relieve symptoms associated with obstruction of the bile duct.

Cook’s family of Evolution stents 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 patent pending Flexor Plus™ technology and remains flexible yet firm enough to be navigated through difficult paths in the anatomy.

The Evolution biliary stent’s woven construction is designed to maintain patency and specifically to aid in preventing stent migration after placement.

The device gained CE mark approval in the spring of 2012, and more than 1,200 stents have been placed in patients since then. It will be available across the United States in July.

The newly cleared biliary stent adds to Cook’s line of Evolution controlled-release stents for the gastrointestinal (GI) tract. The Evolution stent line includes biliary, colonic, duodenal and esophageal options.

Company comments

“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.”

References 

¹ Millennium Research Group. US Markets for Gastrointestinal Endoscopy Devices 2010. Toronto, Canada: Millennium Research Group; 2010.

Source: Cook Medical