FDA Clears Cook Medical’s New Stent
Cook Medical's new Evolution Colonic Controlled-Release Stent. Courtesy of Cook Medical.
By Jeremy Summers, NCBiotech Writer
Earlier today, Cook Medical received clearance from the U.S. Food and Drug Administration for its new product, the Evolution Colonic Controlled-Release Stent.
The device was developed at Cook Endoscopy, part of the Cook Medical portfolio of companies, established in Winston-Salem in 1983. The company now has more than 500 employees at its Winston-Salem facility.
The new stent, which expands Cook Medical’s line of Evolution controlled-release stents, alleviates discomfort associated with colonic obstructions caused by malignant neoplasms. The device also helps to relieve large-bowel obstructions before a patient would undergo a colectomy procedure.
The product capitalizes on a unique design that allows physicians greater control and maneuverability for delivering stents that conform to the body’s natural curves. This design provides enhanced expansion and superior wall apposition and combines with the product’s unique delivery system, which utilizes a kink-resistant technology, to allow for greater stability.
This delivery system, which is employed by all of Cook Medical’s Evolution stents, gives physicians a trigger action that both deploys and recalls a length of stent for precise placement. The stent features an endoscopic marker, making it much easier for physicians to define the proximal end of the stent.
The new stent will be especially helpful to patients with colon cancer. The American Cancer Society estimates that more than 103,000 new cases of colon cancer will be diagnosed in the U.S. this year. Some patients with colon cancer may experience colonic obstruction, creating moderate to severe discomfort. Cook Medical’s Evolution colonic stent will help physicians reduce symptoms associated with obstruction, which include abdominal pain, vomiting, nausea, constipation, diarrhea and GI tract bleeding.
“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 Controlled-Release Stent is now available to select physicians across the U.S. and will be released on a wider scale over the next few months.
About Cook Medical
Cook Medical is a family-owned company founded in 1963. The company, which specializes in medical devices, drugs, biological grafts and cell therapies, has created more than 16,000 products, serving more than 40 medical specialties. Headquartered in Bloomington, Indiana, Cook Medical has more than 500 employees at its Winston-Salem facility.