FDA OKs Cook Medical’s Evolution Duodenal Stent

The U.S. Food and Drug Administration has given the nod to Cook Medical Inc.’s Evolutionduodenal controlled-release stent. The 510(k) clearance means the device will be available for immediate delivery in the United States. The approval also extends Bloomington, Ind.-based firm’s line of Evolution products for the treatment of gastric diseases.

According to the company, the new stent expands palliative care options for patients experiencing issues associated with malignant gastric outlet obstruction, a late stage complication of a variety of gastrointestinal-related cancers, with pancreatic cancer being the most common cause. Studies indicate that as many as 50 percent of the malignancies involving the small intestine, including pancreatic, gastric, duodenal and cholangiocarcinoma, occur in the duodenum, the part of the small intestine connected to the stomach. The stent is an option to relieve the symptoms and potentially life-threatening complications resulting from duodenal obstruction, such as abdominal pain, vomiting, malnutrition and aspiration.

“The Evolution duodenal stent includes several product features that are designed to make stent placement easier and more precise for the physician,” said John Lee, professor of clinical medicine at the H.H. Chao Comprehensive Digestive Disease Center at University of California Irvine Medical Center. “These features of the stent allow for better wall apposition and potentially reduce the risk of migration, both of which are essential when treating patients with gastric outlet obstructions.”

In a prospective multicenter European study of 23 patients, 21 patients had significant improvement of symptoms. No early or late complications were recorded after a median follow-up of 8.8 weeks. Twenty-one patients (91.3 percent) were able to tolerate oral intake with a significant improvement of gastric outlet obstruction scoring system score. Preliminary conclusions from researchers stated that the Evolution duodenal stent provided effective palliation for malignant gastric outlet obstruction. Additionally, physicians have now completed enrollment of 110 patients in a separate ongoing prospective multicenter study and final analysis of data is underway, according to the company.

“The design of the stent and delivery system with recapturability make it easier to deploy in hard-to-reach areas such as the distal duodenum,” said Willis Parsons, M.D., medical director of the Northwest Community Hospital Gastroenterology Center. “The stent platform is designed for optimal trackability and maneuverability in difficult angulations, providing superior stability at crucial points during delivery.”

According to Barry Slowey, global business unit leader for Cook Medical’s Endoscopy division: “We’re excited to be expanding our line of Evolution stents by bringing to the US market a stent platform that aids physicians and has been available globally for several years. This stent has been used to treat thousands of patients around the globe, potentially improving quality of life for these patients, and hopefully minimizing the painful symptoms associated with this disease.”

Family-owned and privately held Cook Medical was founded in 1963.