Lumendi's colonoscope stabilizer picks up FDA nod

The DiLumen device stabilizes colonoscopes for endoluminal procedures—treatments for ailments of the colon that do not require incisions in the skin. Image: Lumendi

Lumendi is developing devices to shift invasive gastrointestinal surgeries toward minimally invasive endoluminal procedures—that is, procedures done entirely from within the intestine. The devicemaker earned FDA clearance for its endoscope stabilizer that facilitates endoluminal treatments.

Endoluminal procedures involve inserting a flexible endoscope and other therapeutic devices to locate and treat diseased tissues in the colon. Instead of requiring incisions to perform treatment, endoluminal surgery makes use of the body’s natural openings to treat ailments of the lungs or gastrointestinal tract.

The DiLumen device stabilizes a colonoscope for these incision-free procedures, according to a statement. It comprises a single-use, soft flexible sheath that fits over standard colonoscopes and two balloons, one at the tip of the colonoscope and the other behind the bending section of the colonoscope. When the balloons are inflated, the company said, they create a stable area, which helps clinicians perform precise endoluminal procedures.

The DiLumen device is the first product to come out of a collaboration between Connecticut-based Lumendi and the Minimally Invasive New Technologies program at Weill Cornell Medicine and New York Presbyterian. Endoluminal treatment could potentially replace open surgical or laparoscopic procedures, which could cut down on healthcare costs, according to a statement.

“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,” said Dr. Jeffrey Milsom, chief of colorectal surgery at New York Presbyterian/Weill Cornell, and Dr. Jerome Decosse, a professor of surgery at Weill Cornell, in the release. “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.”

The company plans to kick off a 30-patient, post-approval study early next year.

Auris Surgical Robotics is also working on the minimally invasive and endoscopic surgery front. In June, the FDA cleared its Auris Robotic Endoscopy system as a bronchoscope to visualize and treat lung conditions.