FDA clears Cook Medical's Evolution Duodenal Controlled-Release Stent

Cook Medical announced today that its Evolution^® Duodenal Controlled-Release Stent was recently granted 510(k) clearance by the Food & Drug Administration (FDA). This new stent expands palliative care options for patients experiencing issues associated with malignant gastric outlet obstruction (GOO), a late stage complication of a variety of GI 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 offers these patients a minimally invasive alternative to relieve the symptoms and potentially life-threatening complications resulting from duodenal obstruction, such as abdominal pain, vomiting, malnutrition and aspiration.

The Evolution Duodenal Controlled-Release Stent, the only duodenal stent delivery system that allows for controlled release and recapturability, is designed to provide physicians with precise control and maneuverability to ensure proper placement and potentially reduce complications such as migration and perforation. The Evolution Duodenal stent is uniquely designed with 18 crowns at both the distal and proximal ends, which allow the stent to adapt to the natural curvature of the anatomy. The proximal and distal flanges are designed to reduce the risk of stent migration, while the patented Flexor® catheter with kink-resistant technology provides trackability and maneuverability for deployment in the difficult anatomy of the duodenum.

"The Evolution duodenal stent includes several product features that are designed to make stent placement easier and more precise for the physician," said John G. 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 GOOSS (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 presently underway.

"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 Dr. Willis Parsons, 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."

"The Evolution duodenal stent provides physicians with highly accurate stent placement, reducing the risk of migration, perforation and minimizing the need for repeat procedures," said 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."