FDA Clears Cook Medical’s Esophageal Stent System

The FDA granted 510(k) clearance to Cook Medical for Evolution, the company’s controlled-release esophageal stent system.

Designed to treat patients with esophageal cancer, the product places the stent precisely on a first attempt and may reduce the need for repeat procedures, according to Cook.

When squeezing the stent's trigger-based introducer, a proportional length of the stent is deployed or recaptured. A directional button enables switching from deployment to recapture mode while a “point-of-no-return” mark alerts the physician when recapture is no longer available.

The stent is cleared for use in Europe.