Cook Medical has received the US Food and Drug Administration (FDA) approval for its new Evolution colonic controlled-release stent.
The new stent design features Kink-resistant flexor technology-based delivery system for pushability and stability, and a visible endoscopic marker to define the proximal end of the stent.
Evolution colonic stent is designed to reduce pain and uncomfortable symptoms associated with colonic obstructions including abdominal pain, vomiting, nausea, difficult defecation and GI tract bleeding as well as to relieve large-bowel obstructions prior to colectomy procedures.
The approval is based on a recent international, multi-center study of 80 patients, which is designed to demonstrate the safety and efficacy of the the Evolution stent for use in reducing symptoms as well as act as a bridge to surgery.
The first post-procedure reports that 85% of patients in both groups had mild or no symptoms of abdominal pain, no difficulty in defecating or constipation, no adverse events associated with device malfunction and no deaths were considered to be caused by a device complication.
Cook Medical endoscopy division global business unit leader Barry Slowey said with the new Evolution colonic stent, clinicians now 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," Slowey added.
The company said Evolution colonic stent, which is now available to select physicians across the US, will be widely available in the coming months.