Although colonoscopy exams prevent many colon cancer deaths and are considered the most sensitive method for detecting colorectal cancers, the procedure is not completely effective in preventing cancer cases. EndoChoice Inc. today unveiled research that shows that its new Fuse system significantly improves the accuracy of this procedure and greatly reduces the number of adenomas missed by colonoscopists. EndoChoice will be discussing these clinical trial results and featuring the Fuse system that recently received FDA 510(k) clearance at Digestive Disease Week (DDW) May 18-21 in Orlando.
EndoChoice's Fuse system is a proprietary arrangement of three small cameras at the tip of a flexible GI endoscope. By using three cameras, the Fuse system allows doctors to see nearly twice as much surface area as they can with traditional endoscopes that only use one camera. Because of the folds that occur naturally in the colon and stomach anatomy, problem areas can easily go undetected when using traditional endoscopes. The Fuse system allows GI doctors to see into and behind those folds.
In a multi-center trial conducted in the U.S., Europe and Israel, Prof. Ian Gralnek and a team of researchers performed a series of colonoscopies comparing traditional endoscopes and the new Fuse system. The endoscope used in the first examination was selected randomly. After the first inspection, each patient immediately underwent a second colonoscopy performed by the same doctor, but with the competing endoscope. The 185 patient trial showed traditional colonoscopes missed 42 percent of adenomas, while the Fuse system missed just 8 percent. After 28 adenomas were found using traditional endoscopes another 20 were found by Fuse for an incremental find rate of 71 percent.
"Traditional endoscopes provide up to 170 degrees of forward vision. The advantage of Fuse is that it allows endoscopists to examine twice the anatomy with a wide 330 degree view," said Ian Gralnek, MD, MSHS, FASGE, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology and Department of Gastroenterology, Rambam Health Care Campus. "Our findings are compelling and support the data from previous studies showing the limitations of traditional endoscopes. EndoChoice's innovative Fuse technology dramatically improves the effectiveness of this life-saving procedure."
At the same meeting, EndoChoice announced the FDA had cleared its 510(k) submission for the Fuse system. EndoChoice plans to expand the use of their Fuse system beyond the current pilot sites to more centers around the world this year.
"Since we announced the expansion of our company in January, our teams in Israel, Germany and the U.S. have been working diligently to develop and launch the revolutionary Fuse endoscopy system. This FDA milestone brings us yet another step closer to our mission of serving the GI professionals so they can give the best possible care to their patients," said Mark Gilreath, Founder and CEO "EndoChoice."