Motus GI Holdings publishes results from European study of Pure-Vu system

Motus GI Holdings announced the publication of positive data from a study of the second generation Pure-Vu System in a manuscript titled, “An intraprocedural bowel cleansing system for difficult-to-prepare patients-A multicenter prospective feasibility study,” in the peer-reviewed journal, United European Gastroenterology. The Company’s Pure-Vu System is an FDA-approved and CE-certified bowel cleansing system intended to increase visualization in inadequately prepared colons by offering intraprocedural cleansing. The single arm, international, multicenter colonoscopy study evaluated if an adequate level of bowel cleansing could be achieved with the Pure-Vu System in patients with previous poor bowel preparation. The study enrolled a total of 44 patients with previous poor bowel preparation within the last 2 years. Typically patients with a history of poor bowel prep are prescribed a more aggressive prep regime on their follow up colonoscopy, whereas in this study all patients received a limited bowel preparation followed by intra-procedural bowel cleansing with the Pure-Vu System. The BBPS was assessed before and after segmental washing by the endoscopist who performed the procedure and later by an independent endoscopist. The study exclusion criteria included previous colon resection, previous colorectal cancer, colitis, lower gastrointestinal bleeding with hemodynamic instability, ASAgreater than3, insufficiently corrected anticoagulation disorders, inability to provide informed consent. Results from the study met the primary endpoint, showing a median BBPS increase from 1-2-2 to 3-3-3 with 31.8% and 88.6% of patients adequately prepared before and after using the Pure-Vu System, respectively. The study also met its key secondary endpoints. The study reported a cecal intubation rate was 88.6%, and, in patients with complete colonoscopy, the adequate cleansing rate was 97.5%. Median total procedure time was 26 minutes, of which 5.3 minutes were spent on cleaning. General ease of use was scored with a median of 4 out of 5, representing “as good as conventional colonoscopy.” No serious adverse events occurred.