Cook’s Evolution Colonic Controlled-Release Stent FDA Cleared

Cook Medical‘s Evolution Colonic Controlled-Release Stent has received clearance from the US regulators. The initial rollout will involve pre-selected surgeons with a wider availability following in a few months.

The stent is designed to open up the lumen of obstructed colons to relieve symptoms from malignancies or in preparation for colectomies.

From the announcement:

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.

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 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

Press release: FDA Clears Cook Medical’s Evolution® Colonic Controlled-Release Stent…