Authors: Jorge Humberto Rodriguez-Quintero, MD, David M Pechman, MD
Ovesco Endoscopy AG (Tubingen, Germany) received FDA approval for the Gastroduodenal Full-Thickness Resection Device (FTRD®) Set on June 2, 2020.
The Ovesco FTRD® system is a family of disposable devices that each allow for full-thickness endoscopic resection and tissue diagnosis for different types of gastrointestinal lesions. The FTRD® sets are compatible with standard endoscopes and include the FTRD® cap with preloaded clip and thread, snare integrated into the distal end of the cap, FTRD® hand wheel, thread retriever, endoscopic sleeve with fixation tapes, FTRD® Marking Probe, and FTRD® Grasper. The system is designed to allow tissue transection to occur only after the visceral wall has been sealed, facilitating the acquisition of one en-bloc specimen with minimal thermal injury.
Full-thickness resection allows for endoscopic treatment of subepithelial tumors and epithelial neoplasia with significant fibrosis. It may also offer improved safety relative to endoscopic mucosal/submucosal resection (EMR), which is associated with relatively high complication rates (bleeding and perforation reported in 25% and 0.6-5% of cases, respectively). Of note, the rate of adverse events is especially high with EMR performed in the duodenum, with a reported perforation rate as high as 35% due to the thinner wall of the duodenum and its retroperitoneal fixation.
The gastroduodenal FTRD® set allows for endoscopic full-thickness resection of duodenal lesions. The device is similar in design to the colonic Ovesco FTRD® systems, however it is smaller and includes two additional components, an insertion balloon and guide wire, to allow for easier/safer insertion. A specially-designed anchor is also available to assist with tissue mobilization. It is compatible with size 10.5-12 mm endoscopes with a working channel of at least 3.7mm. The cap diameter is 19.5mm, with a cap depth of 23mm.
The gastroduodenal FTRD® set is approved for resection of non-lifting adenoma (not pretreated), non-lifting recurrent adenoma, small subepithelial tumors, and early carcinoma in the stomach and duodenum. Resection size is limited by the inner cap diameter.
A limitation of the FTRD® system in the upper gastrointestinal tract is the possible need for balloon dilation of the upper esophageal sphincter and pylorus to allow passage of the device, which can be technically challenging. The system should not be used for lesions in the ampullary duodenum due to the risk of clipping the common bile duct.