Cook Medical Announces FDA 510(k) Clearance of Evolution® Controlled Release Esophageal Stent System
June 9, 2008
San Diego, Calif., May 19, 2008 – At the Digestive Disease Week Conference today, 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.
“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 Dr. Todd Baron, of Rochester, Minnesota. “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.
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.
“We are thrilled to introduce Evolution to the market as the first and only recapturable stent deployment system,” said Barry Slowey, vice president of Global Sales and Marketing for Cook Medical's Endoscopy division. “Since launching the first esophageal stent more than 20 years ago, Cook has continued to pioneer new innovations in this market with the goal of improving patient care. With a unique set of features, like the ability to recapture, reposition and control the deployment of the stent, Evolution leapfrogs any other esophageal stent system on the market today.”
The Evolution stent is also cleared for use in Europe. Since its limited launch on February 18, 2008 in select centers, the stent has been utilized in more than forty cases in seven different European countries.
About Cook Medical
Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.