The EndoZip platform offers a single-operator workflow designed to simplify endoscopic sleeve gastroplasty, a minimally invasive treatment for obesity. By automating gastric remodeling, the technology aims to reduce the technical demands of manual suturing and provide a more standardized execution for surgeons. Gemelli hospital, which already utilizes the system commercially following its CE Mark approval in November 2025, now serves as an active research site for the broader EASE study.
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Nitinotes Launches EASE Clinical Trial Procedures in Rome
Under the direction of Prof. Ivo Boskoski at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, the first EASE clinical trial procedures have been completed in Italy. This milestone marks a critical step for Nitinotes as it gathers clinical evidence to support the U.S. regulatory pathway for its EndoZip automated suturing system.
Prof. Boskoski, alongside colleagues Prof. Cristiano Spada and Dr. Vincenzo Bove, is evaluating the safety and effectiveness of the device as it navigates the gap between pharmacotherapy and surgical intervention. Nitinotes CEO Lloyd Diamond noted that this collaboration leverages the institution's expertise in advanced endoscopy to bolster the company's regulatory efforts. The study represents a shift toward more reproducible outcomes in endobariatric care, moving away from the complexities traditionally associated with manual procedures.
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