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.
“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.”
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.
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. 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.