FDA approves Lumendi endoscopic accessory for endolumenal therapy

The DiLumen endoscopic positioning accessory assists with optical visualization, diagnosis, and endoscopic treatment.

Medical device developer Lumendi (Westport, CT) has received FDA clearance for its DiLumen endoscopic accessory, which works to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis, and endoscopic treatment.

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The DiLumen technology stabilizes a colonoscope to facilitate incision-free endolumenal therapeutic procedures, which use a flexible colonoscope and therapeutic devices inserted into the colon to locate and treat diseased tissue while preserving the colon. The device, which was developed in collaboration with the Minimally Invasive New Technologies program (MINT) at Weill Cornell Medicine and New York-Presbyterian (both in New York, NY), eases endoscopic treatment of colonic lesions such as polyps, a common condition that affects millions worldwide. Such treatments may take the place of open surgical or laparoscopic procedures, potentially reducing healthcare costs.

The device consists of a single-use, soft flexible sheath that fits over standard and small-diameter colonoscopes. It employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed and inflated, a stable therapeutic zone (TZ) is created. This TZ facilitates more localized insufflation and manipulation of the colon and provides improved access to lesions to enable endoscopists and surgeons to perform precise endolumenal interventions. Once the procedure is complete, the balloons are deflated and removed along with the colonoscope.

Use of the device during flexible colonoscopy can stabilize a section of colon and facilitate the endoscopic removal of complex adenomas or polyps, with the potential to positively impact patient outcomes, according to Jeffrey Milsom, MD, chief of colorectal surgery at New York-Presbyterian/Weill Cornell Medical Center, co-director of the MINT Program, and a co-inventor of DiLumen. Although reporting of results in patients awaits clinical studies, the device's development team is optimistic that its technology will be transformative in treating digestive diseases, he says.

For more information, please visit www.lumendi.com and www.mint.weill.cornell.edu.

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