Cook Medical's controlled-release esophageal stent receives FDA clearance

Cook MedicalNov 9 2010

Cook Medical's controlled-release esophageal stent fully covered in silicone has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making available yet another advanced solution from Cook Medical, the only full-line supplier of endoscopic devices. The Evolution^® Controlled Release Esophageal Fully Covered Stent is designed to improve quality of life for patients with malignant esophageal strictures and tracheoesophageal fistulas (TEF) by improving the patients' ability to swallow, and its silicone that fully covers the stent helps prevent tumor ingrowth. In addition, the system gives physicians unparalleled control during stent deployment and recapture.

“The addition of the fully covered stent to Cook's existing Evolution product line provides more options to physicians to treat their esophageal cancer patients.”

Esophageal cancer is among the most rapidly increasing malignancies in North America. More than 16,500 new cases of esophageal cancer are diagnosed annually in the U.S., most associated with risk factors such as alcohol consumption, tobacco use, GERD (gastroesophageal reflux disease) and obesity. The vast majority of patients die within a year of diagnosis. An esophageal stent is typically used to open a passage obstructed by a tumor that has advanced beyond surgical treatment. The stent improves the patients ability to eat and swallow, allowing them to maintain a better quality of life even in the end stage of the disease. Stents are also used to treat TEF (tracheoesophageal fistula), an abnormal connection between the trachea and esophagus that can occur congenitally or develop in adults after laryngeal surgery.

"The Evolution Fully Covered Stent offers physicians more control and less stress in stent placement and recapture," said Barry Slowey, global business unit leader for Cook Medical's endoscopy division. "The addition of the fully covered stent to Cook's existing Evolution product line provides more options to physicians to treat their esophageal cancer patients."

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.