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FDA-approved Scope-stabilizing Device Successful in First Human Trials
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Medical device company Lumendi announced the successful completion of the first human trials of its DiLumen device, an accessory for stabilizing colonoscopes that was approved by the FDA in December 2016.
“The device appears very safe and the [therapeutic zone] can reliably be created in both the right and left colon,” Reem Sharaiha, MD, director of bariatric endoscopy and associate director of the Pancreas Program at NewYork-Presbyterian/Weill Cornell Medical Center, said in a press release. “I see the value in the double balloon system to help facilitate and broaden less invasive therapeutic options to treat colonic disease.”
Developed by Lumendi in collaboration with the Minimally Invasive New Technologies Program (MINT) at Weill Cornell Medicine and New York-Presbyterian, the DiLumen Endolumenal Interventional Platform (EIP) is a single-use sleeve that fits over a standard endoscope to stabilize it in the large intestine for improved visualization, diagnosis, and treatment.
The observational registry study, which began enrollment in April 2017, showed the device was safe, with no serious adverse events occurring in any of the 30 patients during routine colonoscopy, and no significant mucosal injuries occurred, which served as the primary safety endpoint.
Further, endoscopists were able to navigate the scope with the device to the cecum — which served as the primary study endpoint — and they were able to create a stable “therapeutic zone” by inflating the double balloon device in both the right and sigmoid colon.
The study also included a sub-group safety analysis of patients who underwent therapeutic interventions during colonoscopy, and a detailed manuscript is being developed, according to a press release.
“These findings support our aim to improve endoscopic interventions and revolutionize colorectal surgery by transforming the paradigm from the traditional surgical approach to a truly minimally invasive one utilizing novel endolumenal-based technology, increasing safety and significantly reducing costs,” Peter Johann, PhD, CEO of Lumendi, said in the press release.
Disclosures: Johann is employed by Lumendi. Healio Gastroenterology and Liver Disease was unable to confirm Sharaiha’s relevant financial disclosures at the time of publication.