Cook Medical Receives FDA Clearance for Colonic Stent

Bloomington, Ind.-based Cook Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Evolution colonic controlled-release stent. This device expands Cook’s already substantial line of Evolution controlled-release stents, and is designed to mute symptoms that cause discomfort associated with colonic obstructions caused by malignant neoplasms and relieve large bowel obstructions prior to colectomy procedures. It does not treat the cause of disease or blockage, but rather alleviates pain or discomfort.

The colonic stent was recently evaluated in an international registry study of 80 patients. Clinical success rates were 97.8 percent for the device’s use for palliating symptoms, and 85.7 percent for use as a bridge to surgery, according to the company. There were no adverse effects caused by device malfunction, and there were no deaths caused by device complication.

The American Cancer Society predicts 103,000 new cases of colon cancer in 2012 in the United States. Sometimes, patients with colon cancer experience a colon obstruction, which besides being painful also can cause more severe symptoms such as vomiting, difficulty defecating and gastrointestinal (GI) tract bleeding.

The Evolution colonic stent and delivery system feature enhanced expansion, better wall apposition, and a delivery system that employs kink-resistant Flexor technology, created by Cook’s Aortic Intervention division and currently used in its Zenith vascular stent system. The Flexor technology is touted to promote stability and pushability in the stent.

Flexor sheaths the stent with braided-to-coiled construction to deliver the necessary trackability and maneuverability for deployment in difficult angulations. The coiled portion provides stability at the crucial point near the proximal end of the stent. A rounded tip is designed to reduce trauma and to aid in traversing abnormal anatomy.

The colonic stent works the same way all other stents in the Evolution line do: It provides physicians with a trigger action that deploys a proportional length of the stent for precise placement, claims Cook. The colonic stent adds a 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 selectively available in the United States, and will soon become more widely available. The Evolution family of stents include fully covered, partially covered, and uncovered esophageal stents, as well as the duodenal stent which received FDA approval in March of 2011.

Founded in 1963, Cook Medical develops medical devices, drugs, biologic grafts and cell therapies to treat a wide range of medical needs. The company is still family owned.