Cook Medical Gets FDA Clearance for Biliary Controlled Release Uncovered Stent for the GI Tract

The device has already been approved in Europe with 1200 in use.  The delivery system with extended precision allows the doctor to recapture the stent or put it in place with the trigger handle.  BD

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WINSTON-SALEM, N.C.--(BUSINESS WIRE)--The Food and Drug Administration has granted 510(k) clearance for the Evolution^® Biliary Controlled-Release Uncovered Stent from Cook Medical. The biliary stent adds to Cook’s line of Evolution controlled-release stents for the gastrointestinal (GI) tract. 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 year¹ 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 aid in preventing stent migration after placement.

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.

http://www.businesswire.com/news/home/20130605005204/en/Cook-Medical-Receives-Clearance-Evolution%C2%AE-Biliary-Controlled-Release