Cook Medical Announces FDA 510(k) Clearance of Evolution® Controlled Release Esophageal Stent System

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Cook Medical announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Evolution® Controlled Release Esophageal Stent System.

Cook Medical announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Evolution® Controlled Release Esophageal Stent System. Designed to improve the quality of life for patients with esophageal cancer, Evolution employs the first and only stent delivery system that enables deployment and recapturability of the stent with unprecedented precision. The ability to place the stent precisely the very first time may reduce the need for repeat procedures.

According to the American Cancer Institute, more than 16,000 new esophageal cancer cases are presented every year in the U.S. Risk factors for esophageal cancer include alcohol consumption, lye indigestion, tobacco, GERD (gastroesophageal reflux disease) and obesity. Typically, an esophageal stent is used in the treatment of esophageal cancer patients whose condition has advanced beyond surgical treatment options. The market for gastrointestinal stenting currently totals $200 million globally, more than fifty percent of which is in the U.S.

Dr. Todd Baron, of Rochester, Minnesota said, 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. 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 it's “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 deployed or 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.

Barry Slowey, vice president of Global Sales and Marketing for Cook Medical's Endoscopy division said, we are thrilled to introduce Evolution to the market as the first and only recapturable stent deployment system.