FDA Clears Cook Medical's Evolution® Colonic Controlled-Release Stent
July 9, 2012
Winston-Salem, N.C., July 9, 2012 — The U.S. Food and Drug Administration (FDA) has granted Cook Medical 510(k) clearance for the Evolution® Colonic Controlled-Release Stent, Cook announced today. The new stent expands Cook's line of Evolution controlled-release stents and is used to palliate uncomfortable symptoms associated with colonic obstructions caused by malignant neoplasms and relieve large-bowel obstructions prior to colectomy procedures. The product's design offers physicians the control and maneuverability required to deliver a stent that conforms to the natural curves of the anatomy.
In a recent multi-center, international registry study of 80 patients, the Evolution Colonic Controlled-Release Stent was evaluated for use in palliation of symptoms and as a bridge to surgery. Resulting clinical success rates were 97.8 percent and 85.7 percent, respectively. At least 85 percent of patients in both groups reported mild or no symptoms of abdominal pain, difficulty defecating or constipation at the first post-procedure report. There were no adverse events associated with device malfunction and no deaths were considered to be caused by a device complication.1
The American Cancer Society estimates that more than 103,000 new cases of colon cancer will be reported in 2012 in the U.S. alone.2 Some patients with colon cancer may experience colonic obstruction, which can be painful and uncomfortable. The Evolution colonic stent helps physicians reduce the symptoms associated with obstruction, which can include abdominal pain, vomiting, nausea, difficult defecation, constipation, diarrhea and GI tract bleeding.
The Evolution Colonic Controlled-Release Stent and delivery system include several features designed to provide control and maneuverability to physicians. These features include a stent design that provides enhanced expansion and better wall apposition and a unique delivery system that employs kink-resistant Flexor® technology for pushability and stability.
The delivery system, which is the same across all Evolution stents, provides physicians with a trigger action that deploys — or recaptures — a proportional length of the stent for precise placement. The Evolution colonic stent also adds a highly visible endoscopic marker to define the proximal end of the stent.
“The new Evolution colonic stent reiterates Cook Medical's commitment to pioneering a full line of efficient, effective products to improve the quality of life in patients who suffer discomfort or pain,” said Barry Slowey, global business unit leader for Cook Medical's Endoscopy division. “Now clinicians have the ability to precisely deploy and recapture colonic stents. That can make it easier to place the stent the first time around, potentially reducing the need for repeat procedures, while increasing efficiency in the GI unit.”
The Evolution colonic stent is now available to select physicians across the United States, and will be widely available in the coming months. The Evolution colonic stent adds to the existing line of Evolution stents, which includes fully covered, partially covered, and uncovered esophageal stents, as well as the duodenal stent which received FDA approval in March of 2011.
About Cook Medical
A global pioneer in medical breakthroughs, Cook Medical is committed to creating effective solutions that benefit millions of patients worldwide. Today, we combine medical devices, drugs, biologic grafts and cell therapies across more than 16,000 products serving more than 40 medical specialties. Founded in 1963 by a visionary who put patient needs and ethical business practices first, Cook is a family-owned company that has created more than 10,000 jobs worldwide. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter and LinkedIn.