News | June 09, 2008

Cook Gets FDA 510(k) Clearance for Controlled Release Esophageal Stent

June 10, 2008 - At the Digestive Disease Week Conference, Cook Medical announced that it has been granted 510(k) clearance from the FDA for use of the Evolution Controlled Release Esophageal Stent System, a stent designed to improve the quality of life for patients with esophageal cancer.

Evolution employs a stent delivery system that enables deployment and recapturability of the stent with reportedly high precision. The ability to place the stent precisely the very first time may reduce the need for repeat procedures.

“Evolution, including the stent and delivery system, is a major step forward in esophageal stenting, offering a new, improved alternative to the traditional push-pull deployment system,” said Todd Baron, M.D., Rochester, MN. “By enabling accurate placement of the stent the first time with its unique delivery system, Evolution may reduce the need for repeat procedures.”

The Evolution stent’s retractable delivery system facilitates direct monitoring of the placement progress throughout the procedure with its point-of-no-return indicator, allowing physicians more controlled placement of the stent. With each squeeze of the stent’s trigger-based introducer, a proportional length of the stent is engineered to deploy or be recaptured. The directional button enables seamless switching from deployment to recapture mode and the “point-of-no-return” mark alerts the physician when recapture is no longer available. However, even after this point repositioning is still an option.

The Evolution Stent is designed with dual flanges that secure the stent, potentially reducing the risk of migration or stent movement after placement, thus eliminating the need for repeat procedures. It is also the only esophageal stent with an internal and external silicone coating, designed to resist tumor ingrowth into the stent and enhances the patients’ ability to swallow food normally instead of eating through a tube.

The Evolution stent is also cleared for use in Europe.

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