Cook Medical’s Evolution Controlled Release Esophageal Fully Covered Stent Gets FDA Clearance

Cook Medical has received FDA approval for company’s Evolution esophageal stent, designed for people with malignant esophageal strictures and tracheoesophageal fistulas. The device helps improve swallowing ability and deters the growth of tumor thanks to its fully silicone surface.

The Evolution Fully Covered Stent is an esophageal stent with silicone internal and external of the stent that resists tumor ingrowth and makes swallowing more comfortable for the patient. It’s also easier to place because the physician does not have to deduce where the covering ends to position it properly in the center of the tumor. The fully covered Evolution is also designed to secure the stent in the esophageal tract, potentially reducing the risk of stent migration after placement and eliminating the need for repeat procedures.
The Evolution Fully Covered Stent builds on technology introduced with the Evolution® Controlled Release Esophageal Stent, which received 510(k) clearance in May 2008. That design employed the first and only delivery system to enable controlled release and recapturability featuring a “point-of-no-return” indicator. With each squeeze of the stent system’s trigger-based introducer, a proportional length of the stent is deployed or recaptured. The directional button switches smoothly from deployment to recapture mode, and the “point-of-no-return” mark alerts the physician when recapture is no longer available – repositioning, however, is still an option.

Press release: FDA Clearance for Fully Covered Esophageal Stent Advances Cancer Care and Patient Comfort …