Cook Medical received 510(k) clearance from the FDA for its Evolution Biliary Controlled-Release Uncovered Stent. The bile duct stent can be positioned, nearly fully deployed, and recaptured for repositioning as needed. A mark is used to signal the point beyond which recapturing is no longer possible.
The stent is designed to prevent displacement post deployment, and is touted to be flexible enough to match the duct’s curvaceous anatomy while being stiff enough to push through it in preparation for deployment. The device was cleared approximately a year ago in Europe and is now expected to become available in the U.S. by next month.
Here’s a video showing the placement of the stent:
Press release: Cook Medical Receives Clearance for Evolution® Biliary Controlled-Release Uncovered Stent…