Lumendi LLC recently announced FDA 510(k) clearance for their new DiLumen device. The endoscopic accessory is designed to assist in the diagnosis of colorectal disease utilizing balloon overtube technology. It can also be used in administering treatment, assisting in incision-free procedures through proper positioning on an endoscope.
DiLumen is being positioning as the inaugural offering in a full line of devices meant to enhance endoscopic treatment options. It features a “single-use, soft flexible sheath that fits over standard and small-diameter colonoscopes.” There are a pair of balloons, one positioned behind the bending section of the colonoscope and the other by the tip. Once deployed and inflated, the balloons create stable, open zone, allowing for greater, clearer access to the treatment area.
The device was developed with the assistance of the Minimally Invasive New Technologies (MINT) program at Weill Cornell Medicine and New York-Presbyterian. In a press release, Jeffrey Milson, MD, chief of colorectal surgery at that facility and co-director of the MINT program, touted the clinical possibilities of DiLumen.
“DiLumen’s use during flexible colonoscopy is an important technical advance in a field that has previously been defined by laparoscopic and open surgical procedures,” says Milson. “DiLumen can stabilize a section of colon and facilitate the endoscopic removal of complex adenomas or polyps, with the potential to positively impact patient outcomes. Although reporting of results in patients awaits clinical studies, we are extremely optimistic that this technology will be transformative in treating digestive diseases,”
Lumendi plans a commercial launch of the device in 2017.