WINSTON-SALEM, N.C.--(Healthcare Sales & Marketing Network)-- 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.1 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,1 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.
In a prospective multicenter European study of 23 patients, 21 patients had significant improvement of symptoms.2 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.
Available for immediate delivery in the U.S., the Evolution duodenal stent extends Cook Medical’s line of Evolution products for the treatment of gastric diseases.
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.Cookmedical.com. Follow Cook Medical on Twitter @Cookmedicalpr and @Cookgastro.
Dr. Parsons is a paid consultant for Cook Medical.
1 Frech EJ, Adler DG. Endoscopic therapy for malignant bowel obstruction. J Support Oncol 2007;5(7):303–10, 319. Gastroenterol 2010;45(10):1217–22.
2 Small intestine. In: Edge SB, Byrd DR, Compton CC, et al., eds. AJCC Cancer Staging Manual. 7th ed. New York, NY: Springer, 2010:127.
3 Hatfield AR, Giovanni M, Siersema PD, et al. Preliminary results from a multicenter, European, prospective evaluation of the new, double flare, duodenal Evolution stent. Gastrointest Endosc. 2009;69(5):AB192-AB193.