The DiLumen platform is a non-sterile, single-use sleeve that fits over a standard endoscope, stabilizing it and allowing for optical visualization, diagnosis and treatment.
Here’s what you should know:
1. Researchers conducted an observational registry study of 30 patients at a single center. Researchers observed no serious adverse events and reported the device was safe.
2. The DiLumen device reached the cecum and inflated a double balloon device in the right and sigmoid colons successfully.
3. Researchers observed no significant mucosal injuries.
4. Lumendi CEO Peter Johann, MD, said in a 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.”
5. The FDA awarded 510(k) clearance to the device in December 2016.
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