Medical Device Daily Staff Writer
The American Cancer Society (Atlanta) 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. A newly cleared colonic stent from Cook Medical (Bloomington, Indiana) can help physicians reduce the symptoms associated with obstruction, which can include abdominal pain, vomiting, nausea, difficult defecation, constipation, diarrhea and GI tract bleeding.
The firm reported securing FDA 510(k) clearance for such a device, the Evolution Colonic Controlled-Release Stent, late last week.
"[Cook's] device is meant for colonic obstruction from malignancy," Angela Wiant, product manager for Cook's endoscopy division, told Medical Device Daily. "So these patients have cancer that is causing obstruction in their colon. It does work similar to our other Evolution products that are available today, in a sense that it's a controlled release delivery platform."
Each squeeze of the trigger on the handle of the device allows a proportional length of stent to be deployed. 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% and 85.7%, respectively. At least 85% 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 results from [this] registry have been very positive and have been viewed very well by physicians," Wiant said. "These results were presented at the recent Digestive and Disease Week in May, and so I would say that comments from that [conference] show that physicians have been very pleased with the use and the effectiveness of the device."
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.
Cook said the device has the ability to take on a rather substantial market size.
"With the increase in screenings that take place, [along with] a lot of dietary issues, you're seeing the rise of detection in colon cancer," John Devlin, global brand marketing manager for Cook's endoscopy division, told MDD.
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 company said that surgeons who were familiar with the Evolution product line would have no trouble adapting to the colonic 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."
Cook said that the colonic stent will be available to select physicians in the U.S. within the next two weeks and then it will be widely available at the end of this month.
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. The company said that it was developing a fourth stent that would cover the billiary market.
"All four platforms for Evolution, the billiary, the duodenal, the colonic, the esophageal, all function off the same delivery system platform, so they all have controlled release, they're recapturable," Devlin said. "I think we're finally getting to the point where we've got a complete line of stents to offer the physicians and the public in the U.S."